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.
November 29, 2017Medical DevicesFDA
Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.
Hazard: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
November 29, 2017Medical DevicesFDA
Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.
Hazard: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
November 29, 2017Medical DevicesFDA
Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
Hazard: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
November 29, 2017Medical DevicesFDA
Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
Hazard: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
November 29, 2017Medical DevicesFDA
Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.
Hazard: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
November 29, 2017Medical DevicesFDA
Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
Hazard: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
November 29, 2017Medical DevicesFDA
Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
Hazard: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
November 29, 2017Medical DevicesFDA
Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
Hazard: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
November 29, 2017Medical DevicesFDA
Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.
Hazard: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
August 23, 2017Medical DevicesFDA
Exactech, Inc. recalls Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according
Hazard: The Truliant Tibial Trial Handle's pin may disassociate from the main body.
July 19, 2017Medical DevicesFDA
Exactech, Inc. recalls Exactech Optetrak Logic CC 15mm Tibial Augment Screws
Hazard: Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
July 12, 2017Medical DevicesFDA
Exactech, Inc. recalls EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #:
Hazard: Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
July 12, 2017Medical DevicesFDA
Exactech, Inc. recalls EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
Hazard: Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
July 12, 2017Medical DevicesFDA
Exactech, Inc. recalls EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
Hazard: Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
July 12, 2017Medical DevicesFDA
Exactech, Inc. recalls EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
Hazard: Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
July 12, 2017Medical DevicesFDA
Exactech, Inc. recalls EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
Hazard: Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
July 12, 2017Medical DevicesFDA
Exactech, Inc. recalls EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
Hazard: Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
July 12, 2017Medical DevicesFDA
Exactech, Inc. recalls Logic Fit Tibial Tamp Head
Hazard: The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
July 5, 2017Medical DevicesFDA
Exactech, Inc. recalls Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system compo
Hazard: The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.
January 25, 2017Medical DevicesFDA
Exactech, Inc. recalls Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
Hazard: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
January 25, 2017Medical DevicesFDA
Exactech, Inc. recalls AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
Hazard: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
January 25, 2017Medical DevicesFDA
Exactech, Inc. recalls Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Hazard: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
December 28, 2016Medical DevicesFDA
Exactech, Inc. recalls Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Hazard: Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
July 13, 2016Medical DevicesFDA
Exactech, Inc. recalls Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indic
Hazard: Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
July 13, 2016Medical DevicesFDA
Exactech, Inc. recalls Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral s
Hazard: Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
June 8, 2016Medical DevicesFDA
Exactech, Inc. recalls Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11;
Hazard: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
June 8, 2016Medical DevicesFDA
Exactech, Inc. recalls Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use i
Hazard: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
June 8, 2016Medical DevicesFDA
Exactech, Inc. recalls Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in p
Hazard: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
June 8, 2016Medical DevicesFDA
Exactech, Inc. recalls Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in p
Hazard: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
June 8, 2016Medical DevicesFDA
Exactech, Inc. recalls Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use
Hazard: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.