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Recall Observatory FDA recall evidence

Device product

RECON DRILL 6MM X 439MM; 14-443023 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-2241-2018

May 16, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 80193
Status
Terminated
Classification
Class II
Quantity
248
Official record key
device-enforcement:Z-2241-2018

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: 001360 008170 106320 330040 952200 924770 446470 446480 337720 032750 971520 957780 295550

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