FDA Device recall Z-1139-2017
Empowr PS Knee Tibial Insert
- FDA Device
- Class II
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class II recall of Empowr PS Knee Tibial Insert by Encore Medical, citing the Empowr PS Insert was reported as missing the impaction slot feature.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1139-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-10 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Encore Medical |
| Distribution | US |
Product
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
Reason
The Empowr PS Insert was reported as missing the impaction slot feature.
Identifiers
| code_info | 035U1000 |
|---|
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-1139-2017%22
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