Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ.
FDA device recall Z-2236-2024 · posted 2024-06-28 · Open, Classified
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- 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.
- Action taken
- 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 .
- Root cause
- Other
- Status
- Open, Classified
- Product code
- KWY
- Quantity affected
- 589 units
- Distribution
- Worldwide - US distribution in Puerto Rico and the countries of Great Britain, Japan.
- Date initiated
- 2024-04-26
- Date posted
- 2024-06-28
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS (K013211) | Exactech, Inc. | 2001-12-05 |