EMPOWR Porous Knee System TIBIAL PUNCH — Class II medical device recall Z-0329-2018
Terminated recall by Encore Medical, Lp, reported 2018-01-17, distributed in CA. The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be plac
| Recall number | Z-0329-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2017-12-12 |
| Classified | 2018-01-10 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2022-06-13 |
| Distributed | CA |
| Quantity | 2 units |
| Lot numbers | 252564 |
| Model numbers | 801-05-204 |
Product
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
Reason for recall
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
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-0329-2018. 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.