Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. Th
FDA device recall Z-1698-2012 · posted 2012-06-01 · Terminated
Recall details
- Recalling firm
- Genesys Orthopedic Systems, LLC
- Reason for recall
- The inserters have the potential to break.
- Action taken
- Genesys Orthopedic Systems, LLC decided to recall the affected product and called their customers on August 24, 2011. The firm removed the inserters from distribution from 8/24-31/2011.
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 4 inserters
- Distribution
- Nationwide Distribution including Florida and Texas.
- Date initiated
- 2011-08-24
- Date posted
- 2012-06-01
- Date terminated
- 2012-12-04
- Location
- Austin, TX
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENESYS SPINE INTERBODY FUSION SYSTEM (K103034) | Genesys Spine | 2010-12-10 |