FDA recall Z-1471-2018

Zimmer Biomet, Inc. · Class II · device

Product

Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00

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-1471-2018