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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 Insertersee related information
Date Initiated by FirmAugust 24, 2011
Date PostedJune 01, 2012
Recall Status1 Terminated 3 on December 04, 2012
Recall NumberZ-1698-2012
Recall Event ID 61623
510(K)NumberK103034 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductTransforminal 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 ContactMr. William Sowers
512-381-7070
Manufacturer Reason
for Recall		The inserters have the potential to break.
FDA Determined
Cause 2		Reprocessing Controls
ActionGenesys 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 Commerce4 inserters
DistributionNationwide Distribution including Florida and Texas.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MAX
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