Exactech, Inc.: Medical Device Recalls in 2017

According to to data from the FDA, there were 49 medical device recalls made by Exactech, Inc. in 2017. See the details of the recalls below.

You can see similar recalls for other firms.

• AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
• Exactech Optetrak Logic CC 15mm Tibial Augment Screws
• Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
• Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
• Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
• Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
• Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.
• Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
• Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
• EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
• EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
• EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
• Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.
• EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
• Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibial Trial Handle
• Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
• Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.
• Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
• Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
• Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.
• EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
• Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
• Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .
• Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
• Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
• Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip
• Logic Fit Tibial Tamp Head
• Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.
• Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. Indicated for cemented use only.
• Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
• Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.
• EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01