FDA Recall
Terminated
Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patients spine by threading the implant onto the tip of the inserter shaft. Once the implant is seated within the vertebrae the inserter is removed by unthreading the inserter from the implant.
Recall: Z-1698-2012
·
Initiated August 24, 2011
Recall
- Recall Number
- Z-1698-2012
- Event Number
- 61623
- Firm
- Genesys Orthopedic Systems, LLC
- FEI Number
- 3008455034
- Product Code
- MAX
- Status
- Terminated
- Root Cause
- Reprocessing Controls
- Initiated
- August 24, 2011
- Posted
- June 1, 2012
- Terminated
- December 4, 2012
- Address
- 1250 S Capital Of Texas Hwy, Bldg # 3 Suite 600, Austin, TX, 78746-6446
Description
Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patients spine by threading the implant onto the tip of the inserter shaft. Once the implant is seated within the vertebrae the inserter is removed by unthreading the inserter from the implant.
Reason
The inserters have the potential to break.
Action
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.
Distribution
Nationwide Distribution including Florida and Texas.
Quantity
4 inserters