Exactech, Inc.
149 recalls on record · Latest: Nov 26, 2025
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
FDA Devices Moderate Nov 29, 2017
Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, 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 f…
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 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 conventi…
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 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…
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 ma…
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 arthrop…
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 arthropla…
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 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…
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 tissu…
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 …
FDA Devices Moderate Apr 29, 2015
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
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 join…
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 …
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 or…
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…
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 indic…
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, F…
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, F…
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, F…
FDA Devices Moderate Sep 12, 2012
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-…
FDA Devices Moderate Aug 29, 2012
OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Compon…
FDA Devices Moderate Aug 8, 2012
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
FDA Devices Moderate Aug 8, 2012
Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
FDA Devices Moderate Aug 8, 2012
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
FDA Devices Moderate Aug 8, 2012
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
FDA Devices Moderate Aug 8, 2012
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
FDA Devices Moderate Aug 8, 2012
Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
FDA Devices Moderate Aug 1, 2012
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL …
FDA Devices Moderate Aug 1, 2012