FDA recall Z-1465-2018

Product

M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00

Reason for recall

Potential failure of sterile packaging seal.

Distribution

US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad

Key facts

Status

Terminated

Initiation date

2018-03-26

Report date

2018-05-02

Termination date

2020-11-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1465-2018