PlainRecalls
FDA Devices Moderate Class II Terminated

Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.

Reported: March 26, 2014 Initiated: February 26, 2014 #Z-1244-2014

Product Description

Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.

Reason for Recall

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

Details

Recalling Firm
Biomet, Inc.
Units Affected
6
Distribution
Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.. Recalled by Biomet, Inc.. Units affected: 6.
Why was this product recalled?
Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 26, 2014. Severity: Moderate. Recall number: Z-1244-2014.