Recall Z-2118-2021 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral, 36mm. Orthopedic hip implant component.
| Date | Jul 22, 2021 (initiated Jun 29, 2021) |
| Status | Open, Classified |
| Reason | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm issued "URGENT MEDICAL DEVICE CORRECTION" letters dated 6/28/2021 via email on 6/29/2021 that were addressed to the attention of Exactech Agents, Representatives, and Distributors in possession of affected products. |
| Quantity | 89,050 total |
| Distribution | Distribution US nationwide. |
| FDA record | Open on fda.gov |