Z-2241-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2018
- Initiation Date
- May 16, 2018
- Termination Date
- April 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 248
Product Description
RECON DRILL 6MM X 439MM; 14-443023 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
001360 008170 106320 330040 952200 924770 446470 446480 337720 032750 971520 957780 295550