Zimmer Biomet, Inc. recalls BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws…

Recall date

May 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2232-2018

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 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.