FDA recall Z-1476-2018

Product

ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00

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-1476-2018