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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter see related information
Date Initiated by Firm August 24, 2011
Date Posted June 01, 2012
Recall Status1 Terminated 3 on December 04, 2012
Recall Number Z-1698-2012
Recall Event ID 61623
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 TX 78746-6446
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = GENESYS SPINE
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