Z-1698-2012

Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion...

Name: Z-1698-2012 Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion...
Creator: Genesys Orthopedic Systems, LLC
Published: 2011-08-24
License: https://open.fda.gov/license/

Genesys Spine / initiated 2011-08-24 / Terminated

FDA source

Genesys Orthopedic Systems, LLC began a recall of Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. The TLIF PEEK inserter is used to... on 2011-08-24. The reason FDA records is "The inserters have the potential to break". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1698-2012
Status: Terminated
Initiated: 2011-08-24
Posted: 2012-06-01
Terminated: 2012-12-04
Recalling firm: Genesys Spine
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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: The inserters have the potential to break.
FDA 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 in commerce: 4 inserters
Distribution: Nationwide Distribution including Florida and Texas.
Product codes and lots: Model GP200. The four inserters were labeled with GP 200, Lot #1086.

Product code MAX

K103034Class IIGenesys Spine Interbody Fusion SystemGenesys Spine / cleared 2010-12-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)