Z-2237-2018 Class II Terminated
FDA device recall Z-2237-2018 was initiated by Zimmer Biomet, Inc. on May 16, 2018 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Apr 5, 2024). Affected quantity: 832.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 27, 2018
- Initiation Date
- May 16, 2018
- Termination Date
- Apr 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 832
Product Description
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.
Reason for Recall
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.
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2237-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026