PlainRecalls
FDA Devices Moderate Class II Terminated

Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.

Reported: December 12, 2018 Initiated: October 22, 2018 #Z-0531-2019

Product Description

Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.

Reason for Recall

Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
4122
Distribution
Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.. Recalled by Zimmer Biomet, Inc.. Units affected: 4122.
Why was this product recalled?
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Which agency issued this recall?
This recall was issued by the FDA Devices on December 12, 2018. Severity: Moderate. Recall number: Z-0531-2019.