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Recall Observatory FDA recall evidence

Device product

G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 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.

Z-2238-2018

May 16, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 80193
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-2238-2018

Official wording

Reason: 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.

Code information: 143206 281765

Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile barrier failure