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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 Recall
Cynch Lordotic TPLlF Implant
see related information
Date Posted March 10, 2013
Recall Status1 Terminated on May 17, 2013
Recall Number Z-0932-2013
Recall Event ID 62993
Premarket Notification
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/
Manufacturer
Spine Smith Partners LP
93 Red River St
Austin, Texas 78701-4216
For Additional Information Contact Clifton Naivar
512-637-2097
Manufacturer Reason
for Recall
Implants were incorrectly laser marked as 23mm instead of 28mm.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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 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 = SPINE SMITH PARTNERS L.P.
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