Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 2,396 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infection risk due to sterile barrier failure) where no specific injuries or illnesses have been reported in the source text, aligning with the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 2,396 units of 3.2mm x 560mm CoCr Thd Tip trauma guide wires (Catalog Number 14-441053). These devices are intended to be used as guide pins for the insertion of implants, such as cannulated screws and intramedullary nails, and for drilling bone.
The recall is being conducted due to insufficient packaging design verification and an occurrence rate of complaints for sterile barrier failure that exceeds expected levels. Guide wires packaged in the affected configuration have the potential for sterile barrier breach, which creates a possible risk for infection.
The affected units were distributed worldwide, including the United States (nationwide) and Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and the Netherlands. Healthcare providers and facilities should stop using the affected guide wires and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 2,396
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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