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 a potential failure of the sterile packaging seal.
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 potential sterile packaging failure, which poses a risk of infection or harm if the device is used, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 19,483 units of the Zimmer Natural Nail System Tear Drop Guide Wire (2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01). The recall is issued because of 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 specific lot numbers involved are 63733044, 63748390, 63748391, 77006546, 77006547, and 77006548.
Healthcare providers and consumers should check their inventory for these specific item and lot numbers. If the sterile packaging seal is compromised, the product should not be used. Users should contact Zimmer Biomet for further instructions on how to return or dispose of the affected devices.
The recalled product
- Product
- Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 19,483
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 63733044 63748390 63748391 77006546 77006547 77006548
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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