Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires
Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to potential sterile packaging seal failures.
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, which typically indicates a reasonable probability of temporary or medically reversible health consequences. The hazard is a potential sterile packaging seal failure, which is a packaging integrity issue rather than a direct product defect causing injury.
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, 70 cm length; Item Number: 47-2490-098-00). The recall is due to a potential failure of the sterile packaging seal.
The affected products were distributed in the United States and in Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, the Netherlands, and Trinidad. The recall covers specific lot numbers, including 63631729, 63638177, and 63645647, among others listed in the agency record.
Healthcare providers and facilities should check their inventory for the affected item numbers and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or the designated recall coordinator.
The recalled product
- Product
- Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00
- 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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