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 markings on the distal face of the instruments are mis-oriented by 180®. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the A/P direction is critical to making proper anterior, posterior, and chamfer cuts to fit the femoral implant. |
| Product | FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139 |
| Quantity | 10 units |
| Distribution | US Distribution to TX and GA. |
| Initiated | 2015-06-24 |
| Classified | 2015-07-27 |
| Terminated | 2016-06-24 |
| Recall number | Z-2262-2015 |
| 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-2262-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71663/
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