• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter
see related information
Date Posted June 01, 2012
Recall Status1 Terminated on December 04, 2012
Recall Number Z-1698-2012
Recall Event ID 61623
Premarket Notification
510(K) Number
K103034 
Product Classification Intervertebral Fusion Device With Bone Graft, Lumbar - Product Code MAX
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.
Code Information Model GP200. The four inserters were labeled with GP 200, Lot #1086.
Recalling Firm/
Manufacturer
Genesys Orthopedic Systems, LLC
1250 S Capital Of Texas Hwy
Bldg #3, Suite 600
Austin, Texas 78746-6446
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. William Sowers
512-381-7070
Manufacturer Reason
for Recall
The inserters have the potential to break.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = GENESYS SPINE
-
-