The Recall Desk
ModerateFDA (Devices)·Z-0550-2018·Announced 2018-02-14

Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

Zimmer Biomet is recalling 10,116 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

What this means for you

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: This is a voluntary precautionary recall due to a packaging design verification gap, with no reported injuries or illnesses, fitting the Moderate severity criteria.

Plain-English summary

Zimmer Biomet, Inc. is recalling 10,116 units of the Natural Nail System Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm length (Item Number 47-2490-098-00). The recall affects all lot numbers with an expiry date before April 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.

The recalled product

Product
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 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 impla
Affected units
10,116

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 April 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 →