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

• Date Initiated by Firm: April 04, 2013
• Date Posted: May 08, 2013
• Recall Status: Terminated on August 07, 2013
• Recall Number: Z-1276-2013
• Recall Event ID: 64988
• 510(K)Number: K111471
• Product Classification: Fastener, fixation, nondegradable, soft tissue - Product Code MBI
• Product: ExoShape 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
• Recalling Firm/ Manufacturer: Medshape Solutions, INC.; 1575 Northside Dr Nw Ste 440; Atlanta GA 30318-4211
• For Additional Information Contact: Becky 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: Error in labeling
• Action: Medshape 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 Commerce: 26
• Distribution: Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
• 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 = MBI and Original Applicant = MEDSHAPE SOLUTIONS, INC