Empowr PS Knee System Box Cut Guide — Class II medical device recall Z-0325-2017
Terminated recall by Encore Medical, Lp, reported 2016-11-09. It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the b
| Recall number | Z-0325-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2016-09-19 |
| Classified | 2016-10-28 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2017-10-20 |
| Quantity | 436 units |
Product
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0325-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.