Exactech Recalls
211 recalls on record · August 1, 2012 to March 18, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-28-XX, Acumatch
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-36-XX, MCS +5GX
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GX
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 28, 2021Medical DevicesFDA
Exactech, Inc. recalls Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GX
Hazard: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
July 7, 2021Medical DevicesFDA
Exactech, Inc. recalls Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following c
Hazard: The HAT trial contains a retaining ring that has shown the potential to disengage during use.
January 27, 2021Medical DevicesFDA
Exactech, Inc. recalls Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Hazard: Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
November 25, 2020Medical DevicesFDA
Exactech, Inc. recalls Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
Hazard: The product may be mislabeled.
November 25, 2020Medical DevicesFDA
Exactech, Inc. recalls Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Hazard: The product may be mislabeled.
November 4, 2020Medical DevicesFDA
Exactech, Inc. recalls Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for ceme
Hazard: The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
November 4, 2020Medical DevicesFDA
Exactech, Inc. recalls Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemen
Hazard: The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
October 7, 2020Medical DevicesFDA
Exactech, Inc. recalls Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
Hazard: Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
October 7, 2020Medical DevicesFDA
Exactech, Inc. recalls Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
Hazard: Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
September 9, 2020Medical DevicesFDA
Exactech, Inc. recalls The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Hazard: The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size is 4.
March 4, 2020Medical DevicesFDA
Exactech, Inc. recalls Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis
Hazard: These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
February 5, 2020Medical DevicesFDA
Exactech, Inc. recalls Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe
Hazard: Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.
February 5, 2020Medical DevicesFDA
Exactech, Inc. recalls Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe S
Hazard: Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.
November 20, 2019Medical DevicesFDA
Exactech, Inc. recalls 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the
Hazard: Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
October 30, 2019Medical DevicesFDA
Exactech, Inc. recalls Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder Syste
Hazard: Potential for the wire to fracture at the threads and remain in the glenoid.
September 18, 2019Medical DevicesFDA
Exactech, Inc. recalls Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system component
Hazard: The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
June 5, 2019Medical DevicesFDA
Exactech, Inc. recalls Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Hazard: The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
June 5, 2019Medical DevicesFDA
Exactech, Inc. recalls Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Hazard: The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
June 5, 2019Medical DevicesFDA
Exactech, Inc. recalls Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Hazard: The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
May 1, 2019Medical DevicesFDA
Exactech, Inc. recalls Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorot
Hazard: 2.5 Truliant Fit Trays were mismarked as 3
March 6, 2019Medical DevicesFDA
Exactech, Inc. recalls Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally m
Hazard: Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended .
October 10, 2018Medical DevicesFDA
Exactech, Inc. recalls Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Hazard: The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.
September 26, 2018Medical DevicesFDA
Exactech, Inc. recalls Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skelet
Hazard: Potentially have non-conforming internal threads.
September 12, 2018Medical DevicesFDA
Exactech, Inc. recalls Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Hazard: Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628.
February 21, 2018Medical DevicesFDA
Exactech, Inc. recalls Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Hazard: Vix Bit may fracture during use.