Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 3,764 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging seal may compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The defect compromises the sterility of a single-use surgical instrument, which poses a significant risk of infection or serious injury during orthopaedic surgery, fitting the criteria for a Severe rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling 3,764 units of the Zimmer Natural Nail System Tear Drop Guide Wire (Item Number 47-2490-097-01). These are single-use surgical instruments used during orthopaedic surgery for the implantation of a prosthesis. The recall affects all lots expiring prior to September 30, 2023.
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, which is critical for single-use surgical instruments. The affected products were distributed worldwide, including in the United States, Canada, Australia, Brazil, Chile, Hong Kong, Japan, Malaysia, the Netherlands, Nicaragua, Singapore, and Taiwan.
Healthcare providers and facilities that have received these products should stop using them immediately. Zimmer Biomet is managing the recall to ensure that compromised units are removed from circulation.
The recalled product
- Product
- Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 3,764
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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