Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 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 breach) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling various trauma guide wires, specifically the Drill Pt Guide Wire 3.2mmx98cm (Code 469360), due to insufficient packaging design verification. The recall is triggered by an occurrence rate of complaints regarding 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 defective packaging configuration has the potential for a sterile barrier breach, which creates a possible risk for infection in patients using the devices.
The recall involves 10 units of the product. Distribution was 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 patients should contact Zimmer Biomet for further instructions on how to handle the affected devices.
The recalled product
- Product
- DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 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
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 932270
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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