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Zimmer Biomet, Inc. recalls G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws a
Recalled June 27, 2018 · FDA recall Z-2237-2018 · Zimmer Biomet
Hazard
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. · FDA Class II
Units
832
Sold at
Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
Description
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.
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.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →