FDA-Device2019-12-11Class II

Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

Zimmer Biomet, Inc.
Hazard

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

Sold states
Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand
Affected count
26 units
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0594-2020

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