FDA Device recall Z-0766-2017
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabil…
- FDA Device
- Class II
- terminated
- Published 2016-12-21
On 2016-12-21 the FDA classified a Class II recall of Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabil… by Encore Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0766-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-19 |
| Published | 2016-12-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Encore Medical |
| Distribution | US |
Product
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant
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.
Identifiers
| code_info | 202351L01, 202351L02, 202351L03, 202351L04, 202351L05, 202351L06, 202351L07, 202351L08, 202351L09, 203779L09, 202351L10, 203779L10, 203203L01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0766-2017%22
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