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 | Terminated |
| Reason | 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. |
| Product | EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery. |
| Quantity | 2 units |
| Distribution | One medical device distributor in California. |
| Initiated | 2017-12-12 |
| Classified | 2018-01-10 |
| Terminated | 2022-06-13 |
| Recall number | Z-0328-2018 |
| 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-0328-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78727/
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