Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterile 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 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 potential failure of sterile packaging on a medical device, which poses a risk of infection or harm, 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, 100 cm Length; Item Number: 47-2490-097-01). 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 specific lot numbers involved are 63631719, 63668698, 63705230, 63705231, 63731168, 63771071, and 63787479.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected guide wires. Patients who have had these devices implanted should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
- 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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