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

HipLOC CHS Plate/Lag Screw Introducer — recall Z-0885-2016

U.S. FDA — Device Enforcement · United States · 2016-02-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0885-2016
Date of alert
2016-02-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet, Inc.
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 Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.
Reported risk: A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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