Empowr Knee System Product Usage: Non-porous proximal tibial… — Class II medical device recall Z-0711-2017
Terminated recall by Encore Medical, Lp, reported 2016-12-14, distributed nationwide. A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the
| Recall number | Z-0711-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2016-11-15 |
| Classified | 2016-12-06 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2017-01-20 |
| Distributed | Nationwide (US) |
| Quantity | 7 units |
| Reason classes | labeling |
Product
Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
Reason for recall
A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus.
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-0711-2017. 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.