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 | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side. |
| Product | Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant. |
| Quantity | 436 units |
| Distribution | US |
| Initiated | 2016-09-19 |
| Classified | 2016-10-28 |
| Terminated | 2017-10-20 |
| Recall number | Z-0325-2017 |
| 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-0325-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75214/
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