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

Product 4 consists of all products under product code HWC, and same… — recall Z-1102-2016

U.S. FDA — Device Enforcement · United States · 2016-01-11 · Class II

As described by U.S. FDA — Device Enforcement: Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X 32 CORT SCREW CRUCI 47482003403 2.0 X 34 CORT SCREW CRUCI 47482003603 2.0 X 36 CORT SCREW CRUCI 47482003803 2.0 X

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1102-2016
Date of alert
2016-01-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Manufacturing B.V.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide Distribution
Reported risk: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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