Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling specific trauma guide wires because packaging defects may allow sterile barrier breaches, creating a potential 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 from sterile barrier failure) where the source text does not explicitly report that injuries or illnesses have occurred, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling various trauma guide wires, including the Ball Tip Guide Wire 3.2mmx55cm (Catalog No. 469055). The recall is due to insufficient packaging design verification and an occurrence rate of complaints for sterile barrier failure that exceeds expected levels.
The affected guide wires 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 packaging configuration used for these devices has the potential for sterile barrier breach, which leads to a possible risk of infection for patients.
The recall involves 1,234 units distributed worldwide, including the United States (nationwide), 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 devices and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 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
- 1,234
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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