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U.S. Department of Health and Human Services

Class 2 Device Recall ExoShape Soft Tissue Fastener 12 mm x 30 mm

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 Class 2 Device Recall ExoShape Soft Tissue Fastener 12 mm x 30 mmsee related information
Date Initiated by FirmApril 04, 2013
Date PostedMay 08, 2013
Recall Status1 Terminated 3 on August 07, 2013
Recall NumberZ-1276-2013
Recall Event ID 64988
510(K)NumberK111471 
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
ProductExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.
Code Information Lot No. 113011-002
FEI Number 3007593722
Recalling Firm/
Manufacturer		 Medshape Solutions, INC.
1575 Northside Dr Nw Ste 440
Atlanta GA 30318-4211
For Additional Information ContactBecky Brown
404-249-9155
Manufacturer Reason
for Recall		Expiration date on the patient label and date on the product carton were not the same.
FDA Determined
Cause 2		Error in labeling
ActionMedshape sent an "URGENT: MEDICAL DEVICE RECALL" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in Commerce26
DistributionNationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
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 = MBI
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