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 infection due to sterile barrier failure, which is a significant health hazard, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling various trauma guide wires, including the Drill Pt Guide Wire 2mm x 60cm (Catalog 469320). The recall is due to insufficient packaging design verification and a higher-than-expected rate of complaints regarding sterile barrier failure.
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 creates a possible risk for infection if the device is used.
The recall involves 34 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 instructions on return or replacement.
The recalled product
- Product
- DRILL PT GUIDE WIRE 2MM X 60CM; 469320 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
- 34
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)
- 932380 409900 603660
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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