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, creating 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 3/5 (High).
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 medical device with a risk of infection due to sterile barrier failure. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Zimmer Biomet, Inc. is recalling various trauma guide wires, including the Ball Tip Guide Wire 3.2mmx98cm (Catalog No. 469060). The recall involves 4,790 units distributed worldwide, including the United States, Canada, Australia, Japan, and several countries in South America and Europe.
The firm is conducting this recall due to insufficient packaging design verification and an occurrence rate of complaints for sterile barrier failure that exceeds expected levels. Guide wires packaged in the affected configuration have the potential for sterile barrier breach, which leads to a possible risk for infection.
These 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 source text does not specify specific instructions for consumers or healthcare providers regarding the handling of these devices.
The recalled product
- Product
- BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 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
- 4,790
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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