FDA Medical Device Recalls (openFDA)
Spine Smith Holdings, LLC: 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 number
- Z-2258-2013
- Recalling firm
- Spine Smith Holdings, LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-07-31
- Posted
- 2013-09-19
- Terminated
- 2014-03-18
- Reason
- The product has the potential to be laser marked as a Medium when it actually is a Small.
- Root cause
- Process control
- 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.
- Quantity
- 32
- Distribution
- Distributed in FL.
- Lot, serial or model codes
- Part Number: 0301-1410, Lot 53AR
- 510(k) numbers
- ["K102090"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3010266937
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28