FDA Device recall Z-0042-2018
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra…
- FDA Device
- Class II
- terminated
- Published 2017-11-01
On 2017-11-01 the FDA classified a Class II recall of EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra… by Encore Medical, citing it was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0042-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-15 |
| Published | 2017-11-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Encore Medical |
| Distribution | US |
Product
EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
Reason
It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.
Identifiers
| code_info | Lot Number 055U1003 |
|---|
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-0042-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.