Ball Tip Guide Wire Trauma Fixation Systems and Ball Time Guide Wire 2mm x 98cm Trauma Fixation systems (2018-05-28)

Starting date:

May 28, 2018

Posting date:

June 6, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66990

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  Reason
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  Affected products

Affected products

1. Ball Tip Guide Wire Trauma Fixation Systems
2. Ball Time Guide Wire 2mm x 98cm Trauma Fixation systems

Reason

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.

Affected products