Zimmer Biomet Recalls Guide Wires Due to Sterile Packaging Seal Failure
Zimmer Biomet is recalling Smooth Guide Wire Bullet Tip products because the sterile packaging seal may fail, potentially compromising sterility.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential sterile packaging seal failure. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19,483 units of Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length (Item Number: 47-2255-008-01). The recall is due to a potential failure of the sterile packaging seal, which could compromise the sterility of the medical device.
The affected products were distributed nationwide in the United States and in Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, the Netherlands, and Trinidad. The recall covers specific lot numbers listed in the official FDA notice.
Healthcare providers and facilities should stop using the affected guide wires and contact Zimmer Biomet for instructions on returning the products. Patients who have had these devices implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 19,483
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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