Z-0536-2013 Class II Terminated
FDA device recall Z-0536-2013 was initiated by Ebi, Llc on September 29, 2012 and is designated Class II. Reason for recall: Broken screw insertor hardness was measured and found to be below the acceptable limits. The recall status is terminated (terminated December 7, 2015). Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2012
- Initiation Date
- September 29, 2012
- Termination Date
- December 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Reason for Recall
Broken screw insertor hardness was measured and found to be below the acceptable limits.
Distribution Pattern
Nationwide Distribution, including the states of MO, TX, and IN.
Code Information
Lot Numbers 540199, 540199-1