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 | After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance. |
| Product | Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction. |
| Quantity | 12 |
| Distribution | U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan. |
| Initiated | 2018-05-14 |
| Classified | 2018-08-31 |
| Terminated | 2020-08-17 |
| Recall number | Z-2967-2018 |
| 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-2967-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80692/
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