Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0548-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 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 either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.

Product Classification:

Class II

Date Initiated: June 5, 2017

Date Posted: February 14, 2018

Recall Number: Z-0548-2018

Event ID: 78219

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1,517 units

Code Information:

All Lot Numbers Expiry Date Before March 2022

Distribution Pattern:

Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore

Voluntary or Mandated:

Voluntary: Firm initiated