PlainRecalls

DePuy Orthopaedics, Inc.

Compiled from official public sources by the publisher.

155 recalls on record · Latest: Apr 10, 2024

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Agency notice ledger

Federal filing book DePuy Orthopaedics, Inc. HEAVY-BOOK · SINGLE-AGENCY

#102 of 14,151 · 155 notices · 0.148% archive

  • BOOK 155 notices
  • RANK #102 of 14,151
  • SHARE 0.148% archive
  • AGENCY FDA Devices (155)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 10, 2024
  • PHOTO Dodge

Nearest notice-volume peer: Dodge (2 notice gap)

DePuy Orthopaedics, Inc. accounts for about 0.148% of the 104,423-notice archive on 155 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How DePuy Orthopaedics, Inc. compares to 14,151 recalling firms

DePuy Orthopaedics, Inc. ranks 102nd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

DePuy Orthopaedics, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

155 102nd of 14151 higher than 14,049 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

DePuy Orthopaedics, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows DePuy Orthopaedics, Inc. holds about 0.148% of archive notices alongside 155 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jun 14, 2017

DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
FDA Devices Moderate Dec 14, 2016

LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
FDA Devices Moderate Nov 30, 2016

ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU
FDA Devices Moderate Feb 17, 2016

SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
FDA Devices Moderate Oct 14, 2015

Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included with the P.F.C.¿ SIGMA¿ Specialist¿ 2 (SP2 / SPII) Primary Knee Instruments, the P.F.C.¿ SIGMA¿ Specialist ¿ 2 (SP2 / SPII) Revision Knee Instruments, and P.F.C. ¿ SIGMA¿ High P
FDA Devices Moderate Jul 29, 2015

ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
FDA Devices Moderate Jul 29, 2015

ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
FDA Devices Moderate Jul 29, 2015

ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
FDA Devices Moderate Jul 29, 2015

ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
FDA Devices Moderate Jul 29, 2015

ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
FDA Devices Moderate Jul 29, 2015

ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
FDA Devices Moderate Jul 29, 2015

ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
FDA Devices Moderate Jul 29, 2015

ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
FDA Devices Moderate Jul 29, 2015

ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
FDA Devices Moderate Jul 29, 2015

ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components.
FDA Devices Moderate Jun 3, 2015

LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
FDA Devices Moderate Jun 3, 2015

LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
FDA Devices Moderate Apr 8, 2015

RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
FDA Devices Moderate Mar 11, 2015

SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but relies instead on close mechanical interlock between the irregular bone surface and the prosthesis.
FDA Devices Moderate Jan 21, 2015

The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the purpose of impaction, extraction, and insertion applications at steps within the surgical procedure. Due to the frequency of its use, two impaction handles are supplied in each kit.
FDA Devices Moderate Jan 14, 2015

Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
FDA Devices Moderate Jan 14, 2015

Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
FDA Devices Moderate Jan 14, 2015

I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush may also be lightly impacted onto the distal femur for additional stability.
FDA Devices Moderate Jan 14, 2015

Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
FDA Devices Moderate Dec 24, 2014

Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
FDA Devices Moderate Nov 19, 2014

ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
FDA Devices Moderate Oct 15, 2014

Charnley PN Retract & Handle, REF 962004000, Non-Sterile-DuPuy International Ltd. The Charnley Pin Retractor and Handle Set is used to facilitate the insertion and extraction of two pins into and out of bone in the incision area, thereby holding the incision soft tissue open during the surgical procedure.
FDA Devices Moderate Oct 15, 2014

RECLAIM Distal Reamer Extension Non Sterile REF 2975-00-500 Intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
FDA Devices Moderate Jul 30, 2014

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Devices Moderate Jul 30, 2014

RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Devices Moderate Jul 30, 2014

RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Devices Moderate Apr 16, 2014

GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin
FDA Devices Moderate Mar 19, 2014

REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and
FDA Devices Moderate Mar 19, 2014

REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral a
FDA Devices Moderate Mar 19, 2014

REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and
FDA Devices Moderate Mar 19, 2014

REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral an
FDA Devices Moderate Mar 19, 2014

REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral a
FDA Devices Moderate Mar 19, 2014

REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral a
FDA Devices Moderate Mar 5, 2014

PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
FDA Devices Moderate Dec 4, 2013

SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty

DePuy Orthopaedics, Inc. carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Frequently Asked Questions

How many federal recall notices name DePuy Orthopaedics, Inc.? ▼
PlainRecalls indexes 155 distinct federal recall events naming DePuy Orthopaedics, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does DePuy Orthopaedics, Inc. sit among other recalling firms? ▼
DePuy Orthopaedics, Inc. ranks #102 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of DePuy Orthopaedics, Inc.'s notices? ▼
FDA Devices accounts for 155 of this firm's 155 indexed notices.
What product category dominates DePuy Orthopaedics, Inc.'s filing book? ▼
Filings for DePuy Orthopaedics, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
DePuy Orthopaedics, Inc.: 155 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming DePuy Orthopaedics, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026