medical Class II Updated 2018-06-27

Zimmer Biomet, Inc. recalls DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be us

Recalled Product

DRILL PT GUIDE WIRE 2MM X 60CM; 469320 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 932380 409900 603660
View official government recall

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