VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis a
FDA device recall Z-2258-2013 · posted 2013-09-19 · Terminated
Recall details
- Recalling firm
- Spine Smith Holdings, LLC
- Reason for recall
- The product has the potential to be laser marked as a Medium when it actually is a Small.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 32
- Distribution
- Distributed in FL.
- Date initiated
- 2013-07-31
- Date posted
- 2013-09-19
- Date terminated
- 2014-03-18
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM (K102090) | Spine Smith Partners L.P. | 2010-09-30 |