FDA-Device2014-03-26Class II

Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.

Biomet, Inc.
Hazard

Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly.

Sold states
Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
Affected count
1
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1242-2014

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