Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling 449 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of infection due to sterile barrier failure, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Zimmer Biomet, Inc. is recalling 449 units of trauma guide wires (product code 469040) 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 recall is being conducted because the packaging configuration used for these devices has the potential for sterile barrier breach. If the sterile barrier is compromised, the device may not be sterile, leading to a possible risk of infection for the patient. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected products 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 that have received these specific guide wires should stop using them and contact Zimmer Biomet for instructions on return or replacement.
The recalled product
- Product
- GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 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
- 449
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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