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

Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM — recall Z-0460-2018

U.S. FDA — Device Enforcement · United States · 2017-08-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0460-2018
Date of alert
2017-08-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer 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 nationwide distribution. Also Portugal and the Netherlands.
Reported risk: During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
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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