PlainRecalls

Synthes (USA) Products LLC

Compiled from official public sources by the publisher.

164 recalls on record · Latest: Apr 8, 2026

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Agency notice ledger

Federal filing book Synthes (USA) Products LLC HEAVY-BOOK · SINGLE-AGENCY

#96 of 14,151 · 164 notices · 0.157% archive

  • BOOK 164 notices
  • RANK #96 of 14,151
  • SHARE 0.157% archive
  • AGENCY FDA Devices (164)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 8, 2026
  • PHOTO Ford,Lincoln

Nearest notice-volume peer: Ford,Lincoln (1 notice gap)

Synthes (USA) Products LLC accounts for about 0.157% of the 104,423-notice archive on 164 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 →

Where Synthes (USA) Products LLC sits among 14,151 recalling firms

Synthes (USA) Products LLC ranks 96th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Synthes (USA) Products LLC vs all firms by recall-notice count

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

164 96th of 14151 higher than 14,055 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

Synthes (USA) Products LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Synthes (USA) Products LLC holds about 0.157% of archive notices alongside 164 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Low Nov 11, 2020

SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.
FDA Devices Low Nov 11, 2020

END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.
FDA Devices Low Nov 11, 2020

END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.
FDA Devices Low Nov 11, 2020

END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.
FDA Devices Low Nov 11, 2020

STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.
FDA Devices Low Nov 11, 2020

DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.
FDA Devices Moderate Aug 26, 2020

DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381
FDA Devices Moderate Nov 20, 2019

MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm with T-Handle Trial Spacer 11mm with T-Handle Trial Spacer 12mm with T-Handle Trial Spacer 13mm with T-Handle Trial Spacer 15mm with T-Handle Trial Spacer 17mm with T-Handle
FDA Devices Moderate Nov 6, 2019

Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
FDA Devices Moderate Oct 31, 2018

3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
FDA Devices Moderate Jun 27, 2018

Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
FDA Devices Moderate Jun 27, 2018

Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
FDA Devices Moderate Jun 27, 2018

Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
FDA Devices Moderate May 30, 2018

Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
FDA Devices Moderate May 16, 2018

Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
FDA Devices Moderate May 16, 2018

Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
FDA Devices Moderate Mar 14, 2018

2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Devices Moderate Mar 14, 2018

Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Devices Moderate Mar 14, 2018

2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Devices Moderate Mar 14, 2018

2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Devices Moderate Mar 14, 2018

3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Devices Moderate Mar 14, 2018

2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Devices Moderate Mar 14, 2018

2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
FDA Devices Moderate Feb 21, 2018

11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
FDA Devices Moderate Mar 8, 2017

PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy
FDA Devices Moderate Feb 8, 2017

Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
FDA Devices Moderate Dec 28, 2016

Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
FDA Devices Moderate Dec 7, 2016

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
FDA Devices Moderate Nov 30, 2016

Extraction Hook - Sterile for TI Cannulated Nails
FDA Devices Moderate Nov 30, 2016

3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
FDA Devices Moderate Nov 30, 2016

3.0 mm Reaming Rod/950 mm, Sterile
FDA Devices Moderate Nov 30, 2016

2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
FDA Devices Moderate Nov 30, 2016

Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
FDA Devices Moderate Nov 30, 2016

2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
FDA Devices Moderate Nov 30, 2016

2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
FDA Devices Moderate Nov 30, 2016

2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
FDA Devices Moderate Nov 30, 2016

3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile
FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
FDA Devices Moderate Aug 24, 2016

TI Single Vector Distractor Body with Left Foot/30mm; Catalog ID 487.965 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
FDA Devices Moderate Aug 17, 2016

Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following systems: - 2.4. mm Titanium LCP Distal Radius Plate System - Titanium LCP Compact Distal Radius System - 2.4 mm Titanium LCP Radial Head Plate Set - Titanium Modular Mini Fragment LCP System - 2.4

FDA Devices Moderate Jul 27, 2016

Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 9519308; 9620447; 9301183; 9409792; 9519303; 9641077; 9301184; 9409791; 9542998; 9641078; 9327510; 9422885; 9554330; 9651850; 9340629; 9351396; 9554329; 9604307; 9347642; 9428332; 9533341; 9661610; 9339162; 9439269; 9574931; 9734868; 9347641; 9485532; 9569618; 9704087; 9351397; 9485534; 9569617; 9734876
FDA Devices Moderate Jul 20, 2016

4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
FDA Devices Moderate Jul 20, 2016

4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
FDA Devices Moderate Jul 20, 2016

6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
FDA Devices Moderate Jul 20, 2016

Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
FDA Devices Moderate Jul 20, 2016

Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

Synthes (USA) Products LLC 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 Synthes (USA) Products LLC? ▼
PlainRecalls indexes 164 distinct federal recall events naming Synthes (USA) Products LLC, 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 Synthes (USA) Products LLC sit among other recalling firms? ▼
Synthes (USA) Products LLC ranks #96 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 Synthes (USA) Products LLC's notices? ▼
FDA Devices accounts for 164 of this firm's 164 indexed notices.
What product category dominates Synthes (USA) Products LLC's filing book? ▼
Filings for Synthes (USA) Products LLC 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.
Synthes (USA) Products LLC: 164 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 Synthes (USA) Products LLC; individual notices remain authoritative on each linked recall page.

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