FDA Medical Device Recalls (openFDA)
Genesys Orthopedic Systems, LLC: 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 number
- Z-1698-2012
- Recalling firm
- Genesys Orthopedic Systems, LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-08-24
- Posted
- 2012-06-01
- Terminated
- 2012-12-04
- Reason
- The inserters have the potential to break.
- Root cause
- Reprocessing Controls
- 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.
- Quantity
- 4 inserters
- Distribution
- Nationwide Distribution including Florida and Texas.
- Lot, serial or model codes
- Model GP200. The four inserters were labeled with GP 200, Lot #1086.
- 510(k) numbers
- ["K103034"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3008455034
- 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