Product Wiki · Recalls · Health Canada — Medical Devices

Ball Tip Guide Wire Trauma Fixation Systems and Ball Time Guide Wire… — recall 61024

Health Canada — Medical Devices · Canada · 2018-06-06 · Type II

As described by Health Canada — Medical Devices: Ball Tip Guide Wire Trauma Fixation Systems and Ball Time Guide Wire 2mm x 98cm Trauma Fixation systems (2018-05-28)

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Agency
Health Canada — Medical Devices
Recall identifier
61024
Date of alert
2018-06-06
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Zimmer Biomet is conducting a medical device recall for various Ball Tip Guide Wires and Drill PT 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. Products with an expiration date prior to May 31, 2028 were packaged in the affected packaging configuration and are subject to this recall. Future production of these products will use a new packaging configuration.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ball-tip-guide-wire-trauma-fix

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