FDA Recall
Terminated
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.
Recall: Z-2258-2013
·
Initiated July 31, 2013
Recall
- Recall Number
- Z-2258-2013
- Event Number
- 65999
- Firm
- Spine Smith Holdings, LLC
- FEI Number
- 3010266937
- Product Code
- MAX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 31, 2013
- Posted
- September 19, 2013
- Terminated
- March 18, 2014
- Address
- 93 Red River St, Austin, TX, 78701-4216
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
The product has the potential to be laser marked as a Medium when it actually is a Small.
Action
The firm decided to remove this lot and verify all of the markings. A stock sweep for mis-marked parts was performed at the time and it is not known why this lot is identified, however an additional stock sweep of all PEEK products from all product lines was performed beginning 07/31/2013 and no additional lots were identified.
Distribution
Distributed in FL.
Quantity
32