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

GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. — recall Z-2234-2018

U.S. FDA — Device Enforcement · United States · 2018-05-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2234-2018
Date of alert
2018-05-16
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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