Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. T

U.S. FDA — Device Enforcement · United States · 2017-09-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0042-2018
Date of alert: 2017-09-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Encore Medical, Lp
Product category: device
Product type: Devices

Reported risk: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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