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[Recalled] Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductHumeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 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 implantation. The guide wire incorporates eithe
Brand / manufacturerZimmer Biomet, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0549-2018
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date05 June 2017

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Zimmer Biomet, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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