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

Recall Z-0326-2018 — DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.

U.S. FDA — Device Enforcement · United States · 2017-12-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0326-2018
Date of alert
2017-12-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Encore Medical, Lp
Product category
device
Product type
Devices
Reported risk: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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