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U.S. Department of Health and Human Services

Class 2 Device Recall Cynch Lordotic TPLlF Implant

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  Class 2 Device Recall Cynch Lordotic TPLlF Implant see related information
Date Initiated by Firm August 24, 2012
Date Posting Updated March 10, 2013
Recall Status1 Terminated 3 on May 17, 2013
Recall Number Z-0932-2013
Recall Event ID 62993
510(K)Number K101085  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
Code Information Part Number: 0609-2809-06, Lot: 39AQ
Recalling Firm/
Spine Smith Partners LP
93 Red River St
Austin TX 78701-4216
For Additional Information Contact Clifton Naivar
Manufacturer Reason
for Recall
Implants were incorrectly laser marked as 23mm instead of 28mm.
FDA Determined
Cause 2
Labeling mix-ups
Action Spine Smith sent a Field Action Notice dated August 24, 2012 to its affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 512-637-2097 for questions concerning this notice.
Quantity in Commerce 3 units
Distribution Distributed in 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 = SPINE SMITH PARTNERS L.P.