Agency classClass IIOur severity:Severe FDA (Devices)·Z-0539-2019·Announced 2018-12-12

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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.
Category: Medical Device — Surgical Instrument
Hazard: sterility-compromise
infection
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.

See all 13 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · sterility compromise