EMPOWR Porous Knee Patella Over Drill — Class II medical device recall Z-1384-2023
Ongoing recall by Encore Medical, LP, reported 2023-04-19, distributed in AL, CA, HI, IN, KS, MD, TX, WA. Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella ove
| Recall number | Z-1384-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2023-02-28 |
| Classified | 2023-04-12 |
| Reported by FDA | 2023-04-19 |
| Distributed | AL, CA, HI, IN, KS, MD, TX, WA |
| Quantity | 29 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00190446238843, 00190446365907 |
| Model numbers | 802-05-104, 802-05-108 |
Product
EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Reason for recall
Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.
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-1384-2023. 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.