Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Packaging Seal Failure
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires 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, and the risk is theoretical rather than confirmed, fitting the criteria for a moderate severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19,483 units of the Zimmer Natural Nail System Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length (Item Number: 47-2490-097-00). 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, including 63609177, 63631715, and 63638172, among others.
Healthcare providers and facilities should check their inventory for the affected item number and lot numbers. If the product is found, it should be removed from use and returned to Zimmer Biomet, Inc. according to the company's instructions.
The recalled product
- Product
- Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
- Manufacturer
- Zimmer Biomet, Inc.
- 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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