Device product
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.
Z-1242-2014
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 67618
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1242-2014
Official wording
Reason: Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly.
Code information: Lot 669420
Distribution pattern: Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
Derived failure modes
-
Labeling or packaging
Incorrect labeling