3.2MM X 560MM COCR THD TIP; 14-441053 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.
Reported: June 27, 2018 Initiated: May 16, 2018 #Z-2242-2018
Product Description
3.2MM X 560MM COCR THD TIP; 14-441053 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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 2396
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
3.2MM X 560MM COCR THD TIP; 14-441053 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.. Recalled by Zimmer Biomet, Inc.. Units affected: 2396.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 27, 2018. Severity: Moderate. Recall number: Z-2242-2018.
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