Brand

Exactech, Inc. Recalls

136 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Exactech, Inc..

136Total Recalls
0Critical
2.4MUnits Affected
Feb 3, 2026Most Recent
All Recalls

Every Exactech, Inc. Recall

Sorted by most recent. Click any recall for full details.

136 recalls
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
Medical Devices·386 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
Medical Devices·573 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
Medical Devices·109 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.
Medical Devices·537 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
Medical Devices·114 affected·Sep 19, 2017
High RiskFDA
Exactech, Inc.
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
Medical Devices·0 affected·May 25, 2017
High RiskFDA
Exactech, Inc.
EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
Medical Devices·2,069 affected·May 25, 2017
High RiskFDA
Exactech, Inc.
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
Medical Devices·198 affected·May 25, 2017
High RiskFDA
Exactech, Inc.
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according t...
Medical Implants·477 affected·May 22, 2017
High RiskFDA
Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by...
Medical Devices·9 affected·May 16, 2017
High RiskFDA
Exactech, Inc.
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage...
Medical Devices·9 affected·May 16, 2017
High RiskFDA
Exactech, Inc.
AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
Medical Devices·12 affected·Nov 7, 2016
High RiskFDA
Exactech, Inc.
Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
Medical Devices·98 affected·Nov 7, 2016
High RiskFDA
Exactech, Inc.
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicate...
Medical Devices·8 affected·May 26, 2016
High RiskFDA
Exactech, Inc.
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip ...
Medical Devices·1 affected·Apr 12, 2016
High RiskFDA
Exactech, Inc.
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total...
Medical Devices·2 affected·Apr 12, 2016
High RiskFDA
Exactech, Inc.
Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total h...
Medical Devices·1 affected·Apr 12, 2016
High RiskFDA
Exactech, Inc.
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit f...
Medical Implants·8 affected·Sep 23, 2015
High RiskFDA
Exactech, Inc.
Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to mani...
Medical Devices·2 affected·May 21, 2015
High RiskFDA
Exactech, Inc.
Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-...
Medical Devices·4 affected·May 21, 2015
High RiskFDA
Exactech, Inc.
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
Medical Implants·112 affected·Feb 13, 2015
High RiskFDA
Exactech, Inc.
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replac...
Medical Implants·10 affected·Mar 7, 2014
High RiskFDA
Exactech, Inc.
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exacte...
Medical Implants·235 affected·Sep 11, 2013
High RiskFDA
Exactech, Inc.
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other d...
Medical Devices·57 affected·May 30, 2013
High RiskFDA
Exactech, Inc.
Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are i...
Medical Devices·26 affected·Nov 5, 2012
High RiskFDA
Exactech, Inc.
Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Syste...
Medical Devices·26 affected·Nov 5, 2012
High RiskFDA
Exactech, Inc.
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Medical Devices·54,877 affected·Jun 15, 2012
High RiskFDA
Exactech, Inc.
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Exactech, Inc.
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Exactech, Inc.
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Ga...
Medical Implants·2 affected·Jan 24, 2012
High RiskFDA
Exactech, Inc.
OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC T...
Medical Implants·70 affected·Oct 17, 2011
High RiskFDA
Exactech, Inc.
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gain...
Surgical Devices·12 affected·Sep 23, 2011
High RiskFDA
Exactech, Inc.
Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Ex...
Medical Devices·16 affected·Sep 23, 2011
High RiskFDA
Exactech, Inc.
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components**...
Medical Devices·193 affected·Aug 19, 2011
High RiskFDA
Exactech, Inc.
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilizati...
Medical Devices·749 affected·Mar 6, 2009