PlainRecalls

Exactech, Inc.

211 recalls on record · Latest: Mar 18, 2026

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Agency notice ledger

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

#64 of 14,151 · 211 notices · 0.202% archive

  • BOOK 211 notices
  • RANK #64 of 14,151
  • SHARE 0.202% archive
  • AGENCY FDA Devices (211)
  • CAT medical devices
  • CATS 1 category
  • LATEST Mar 18, 2026
  • PHOTO Medtronic Vascular

Nearest notice-volume peer: Medtronic Vascular (0 notice gap)

Exactech, Inc. accounts for about 0.202% of the 104,423-notice archive on 211 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 Exactech, Inc. compares to 14,151 recalling firms

Exactech, Inc. ranks 64th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Exactech, Inc. vs all firms by recall-notice count

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

211 64th of 14151 higher than 14,086 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

Exactech, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Exactech, Inc. holds about 0.202% of archive notices alongside 211 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Nov 29, 2017

Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.

FDA Devices Moderate Aug 23, 2017

Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibial Trial Handle

FDA Devices Moderate Jul 19, 2017

Exactech Optetrak Logic CC 15mm Tibial Augment Screws

FDA Devices Moderate Jul 12, 2017

EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01

FDA Devices Moderate Jul 12, 2017

EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46

FDA Devices Moderate Jul 12, 2017

EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46

FDA Devices Moderate Jul 12, 2017

EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46

FDA Devices Moderate Jul 12, 2017

EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01

FDA Devices Moderate Jul 12, 2017

EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01

FDA Devices Moderate Jul 12, 2017

Logic Fit Tibial Tamp Head

FDA Devices Moderate Jul 5, 2017

Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip

FDA Devices Moderate Jan 25, 2017

AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.

FDA Devices Moderate Jan 25, 2017

Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6

FDA Devices Moderate Jan 25, 2017

Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

FDA Devices Moderate Dec 28, 2016

Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

FDA Devices Moderate Jul 13, 2016

Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where s

FDA Devices Moderate Jul 13, 2016

Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone

FDA Devices Moderate Jun 8, 2016

Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.

FDA Devices Moderate Jun 8, 2016

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.

FDA Devices Moderate Jun 8, 2016

Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.

FDA Devices Moderate Jun 8, 2016

Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.

FDA Devices Moderate Jun 8, 2016

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.

FDA Devices Moderate Jun 8, 2016

Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.

FDA Devices Moderate Feb 24, 2016

Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.

FDA Devices Moderate Nov 11, 2015

Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation

FDA Devices Moderate Jul 22, 2015

Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.

FDA Devices Moderate Jul 22, 2015

Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

FDA Devices Moderate Jul 22, 2015

Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previou

FDA Devices Moderate Apr 29, 2015

Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.

FDA Devices Moderate Jan 14, 2015

Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants

FDA Devices Moderate Jul 30, 2014

NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.

FDA Devices Moderate Mar 26, 2014

Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fract

FDA Devices Moderate Feb 12, 2014

***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

FDA Devices Moderate Aug 7, 2013

Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

FDA Devices Moderate Mar 27, 2013

Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.

FDA Devices Moderate Feb 13, 2013

Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.

FDA Devices Moderate Feb 13, 2013

Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.

FDA Devices Moderate Sep 19, 2012

REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

FDA Devices Moderate Sep 19, 2012

REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

FDA Devices Moderate Sep 19, 2012

REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

FDA Devices Moderate Sep 19, 2012

REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

FDA Devices Moderate Sep 19, 2012

REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

Exactech, Inc. carries an outsized archive share

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

Similar recall count

Nearest multi-notice firms by distinct-event totals (211 here — heavy-book).

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Frequently Asked Questions

How many federal recall notices name Exactech, Inc.?
PlainRecalls indexes 211 distinct federal recall events naming Exactech, 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 Exactech, Inc. sit among other recalling firms?
Exactech, Inc. ranks #64 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 Exactech, Inc.'s notices?
FDA Devices accounts for 211 of this firm's 211 indexed notices.
What product category dominates Exactech, Inc.'s filing book?
Filings for Exactech, 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.
Exactech, Inc.: 211 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 Exactech, Inc.; individual notices remain authoritative on each linked recall page.

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