Date Initiated by Firm |
August 24, 2012 |
Date Posted |
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/ Manufacturer |
Spine Smith Partners LP 93 Red River St Austin TX 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 |
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.
|