Zimmer Biomet Recalls Ball Tip Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 26 units of Ball Tip 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 is classified as FDA Class II and involves a risk of infection due to sterile barrier failure, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 26 units of Ball Tip Guide Wires (2.0mm x 60cm; catalog number 469020). These medical 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 was initiated due to insufficient packaging design verification and an occurrence rate of complaints for sterile barrier failure that exceeded expected levels. The affected packaging configuration has the potential for sterile barrier breaches, which could lead to a risk of infection for patients.
The affected units were distributed worldwide, including nationwide in the United States and in 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 units and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 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
- 26
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)
- 271231
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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