Z-2240-2018 Class II Terminated
FDA device recall Z-2240-2018 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: 304.
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
- 304
Product Description
3.2MM X 510MM COCR THD TIP; 14-443053 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
001390 105790 324290 974210 820900 512140 428260 915580 017930 671970 055480 615280 506500 569970 053580 367190 932620 015010 141060 820240 941850 682590 401830
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2240-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026