Class II — Encore Medical, LP
| Recalling firm | ENCORE MEDICAL, L.P. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108 |
| Quantity | 29 |
| Distribution | US: TX, IN, MD, CA, KS, AL, HI, WA |
| Initiated | 2023-02-28 |
| Classified | 2023-04-12 |
| Recall number | Z-1384-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Encore Medical, LP (Z-1384-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91906/
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