FDA recall Z-0595-2020

Product

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

Reason for recall

Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam

Distribution

Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand

Key facts

Status

Terminated

Initiation date

2019-10-25

Report date

2019-12-11

Termination date

2020-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0595-2020