Z-2258-2013 Class II Terminated
FDA device recall Z-2258-2013 was initiated by Spine Smith Holdings, LLC on July 31, 2013 and is designated Class II. Reason for recall: The product has the potential to be laser marked as a Medium when it actually is a Small. The recall status is terminated (terminated March 18, 2014). Affected quantity: 32.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2013
- Initiation Date
- July 31, 2013
- Termination Date
- March 18, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
Product Description
VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.
Reason for Recall
The product has the potential to be laser marked as a Medium when it actually is a Small.
Distribution Pattern
Distributed in FL.
Code Information
Part Number: 0301-1410, Lot 53AR