Empowr PS Knee Tibial Insert — Class II medical device recall Z-1139-2017
Terminated recall by Encore Medical, Lp, reported 2017-02-15, distributed nationwide. The Empowr PS Insert was reported as missing the impaction slot feature.
| Recall number | Z-1139-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2017-01-10 |
| Classified | 2017-02-03 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2017-05-11 |
| Distributed | Nationwide (US) |
| Quantity | 24 units |
| Model numbers | 343-14-709 |
Product
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
Reason for recall
The Empowr PS Insert was reported as missing the impaction slot feature.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1139-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.