FDA recall Z-1475-2018

Zimmer Biomet, Inc. · Class II · device

Product

ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00

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-1475-2018