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

Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona Tibial Resection System. — recall Z-0411-2016

U.S. FDA — Device Enforcement · United States · 2015-11-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0411-2016
Date of alert
2015-11-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
62137112
Reported risk: Complaints that the ratchet teeth of the tube are not latching onto the rod.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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