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.
February 14, 2018Medical DevicesFDA
Exactech, Inc. recalls Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip System
Hazard: Wrong device description of the label identifying the implant
February 7, 2018Medical DevicesFDA
Exactech, Inc. recalls Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally
Hazard: Potentially mislabeled.
February 7, 2018Medical DevicesFDA
Exactech, Inc. recalls Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally
Hazard: Potentially mislabeled.
December 13, 2017Medical DevicesFDA
Exactech, Inc. recalls Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle
Hazard: Possible inner labeling and packaged device not matching the outer label on the box.
December 13, 2017Medical DevicesFDA
Exactech, Inc. recalls Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with an
Hazard: Possible inner labeling and packaged device not matching the outer label on the box.
November 29, 2017Medical DevicesFDA
Exactech, Inc. recalls Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, 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 Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, 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 Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, 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 Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, 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 Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, 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 Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, 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 Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, 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 Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, 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 Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, 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 Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, 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 Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, 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 Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, 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 Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, 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 Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, 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 5F/5T, Beta, Ref 208-04-54, 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 5F/5T, Alpha, Ref 208-04-53, 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 5F/4T, Beta, Ref 208-04-52, 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 5F/4T, Alpha, Ref 208-04-51, 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 4F/4T, Beta, Ref 208-04-44, 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 4F/4T, Alpha, Ref 208-04-43, 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 4F/3T, Beta, Ref 208-04-42, 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 4F/3T, Alpha, Ref 208-04-41, 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 3F/3T, Beta, Ref 208-04-34, 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 3F/3T, Alpha, Ref 208-04-33, 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 3F/2T, Alpha, Ref 208-04-31, 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.