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Recall Observatory FDA recall evidence

Device product

G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 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-2237-2018

May 16, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 80193
Status
Terminated
Classification
Class II
Quantity
832
Official record key
device-enforcement:Z-2237-2018

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: 286530 300210 413620 448170 548100 570250 626810 638980 700950 758900 828020 828040 932250 244880 244890 125970 150380 298880 754180 571170 198490 800020 399250

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