Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0551-2018·Announced 2018-02-14

Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

Zimmer Biomet is recalling 1,631 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates a packaging and design verification issue rather than a direct safety hazard or reported injury, aligning with the 'Moderate' criteria for voluntary precautionary recalls or minor issues.

Plain-English summary

Zimmer Biomet, Inc. is recalling 1,631 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 affects all lot numbers with an expiry date before March 2022.

The recall was initiated because the design verification for the previous packaging configuration (G928) did not cover the 70cm wires. A design verification has since been completed to move the 70cm guide wires to a new packaging configuration, resulting in the removal of products packaged in the previous configuration.

The affected products were distributed nationwide within the U.S.A. and Puerto Rico, as well as internationally in Australia, Brazil, Canada, China, Germany, India, Japan, the Netherlands, and Singapore. These guide wires are used during the initial reaming of the intramedullary canal and assist in guiding the nail during implantation. Healthcare facilities should stop using the affected units and contact Zimmer Biomet for further instructions.

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 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during…
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Surgical Instrument
Hazard: packaging-defect
design-verification
Affected units: 1,631

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)

All Lot Numbers Expiry Date Before March 2022

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · packaging defect