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.
What this means for you
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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