EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-7
FDA device recall Z-1187-2023 · posted 2023-02-27 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size.
- Action taken
- On 12/22/22 recall notices were emailed to surgical agents who were asked to do the following: 1) Pass on the notice to all those within their organization or to any organization where potentially affected products have been transferred. 2) Return affected products. 3) Complete and return the Consignee Reconciliation notice. The following number was provided: Customer Service, 1-800-456-8696 On 2/8/23 recall notices were emailed with an expanded scope.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 216
- Distribution
- US: MN, IL, IN, NY, FL
- Date initiated
- 2022-12-22
- Date posted
- 2023-02-27
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMPOWR VVC TIBIAL INSERT (K180930) | Encore Medical L.P. | 2018-07-09 |