Z-1243-2014 Class II Terminated
FDA device recall Z-1243-2014 was initiated by Biomet, Inc. on Feb 26, 2014 and is designated Class II. Reason for recall: Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly. The recall status is terminated (terminated Jul 7, 2015). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 26, 2014
- Initiation Date
- Feb 26, 2014
- Termination Date
- Jul 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 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.
Distribution Pattern
Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
Code Information
Lot 239430, 239450
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1243-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026