Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 57,241 Natural Nail System Tear Drop Guide Wires because creases in the sealing area may compromise product 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 medical device where a defect compromises sterility, creating a risk of harm (infection) to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 57,241 units of the Zimmer Natural Nail System Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length (Item Number: 47-2490-097-00). These are single-use surgical instruments used during orthopaedic surgery for the implantation of a prosthesis.
The recall was initiated because creases were found in the sealing area on the end opposite of the product's chevron opening. This defect compromises the product's sterility, posing a risk of infection to patients. The affected units are all lots expiring prior to September 30, 2023.
The product was distributed worldwide, including in the United States, Canada, Australia, Brazil, Chile, Hong Kong, Japan, Malaysia, the Netherlands, Nicaragua, Singapore, and Taiwan. Healthcare facilities and distributors should stop using the affected guide wires and contact Zimmer Biomet for instructions on return or disposal.
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 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 57,241
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 (2)
- All lots expiring prior to September 30
- 2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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