Recall Z-2236-2024 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Exactech, Inc.
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
| Date | Jun 28, 2024 (initiated Apr 26, 2024) |
| Status | Open, Classified |
| Reason | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH. |
| Root cause | Other |
| Action | Exactech issued an UREGNT VOLUNTARY MEDICAL DEVICE RECALL notice to its sales representatives on 04/26/2024 via email. The notice explained the issue, clinical impact (risk), and requested the following: Actions to be Taken: " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Distribute this Recall Letter to all the surgeons who have implanted the affected devices. " Send all affected product back to Exactech as outlined in the attached Recall Confirmation Form . |
| Quantity | 589 units |
| Distribution | Worldwide - US distribution in Puerto Rico and the countries of Great Britain, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013211 | MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS Exactech, Inc., Dec 5, 2001 |