Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (
FDA device recall Z-1139-2017 · posted 2017-02-03 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- The Empowr PS Insert was reported as missing the impaction slot feature.
- Action taken
- DJO Global sent an Urgent Field Safety Notice dated January 10, 2017, to all affected customers. The Field Safety Notice instructs the agents to notify all individuals within their organization or to any organization where the potentially affected product has been transferred. Customers with questions should contact customer service at 1-800-456-8696. For questions regarding this recall call 512-832-9500.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 24 units
- Distribution
- Nationwide Distribution to CO, NY, and FL
- Date initiated
- 2017-01-10
- Date posted
- 2017-02-03
- Date terminated
- 2017-05-11
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMPOWR PS Knee System (K160342) | Encore Medical L.P. | 2016-05-19 |