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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64988
Product Type Devices
Status Ongoing
Recalling Firm Medshape Solutions, INC.
City Atlanta
State GA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-04
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot No. 113011-002 Class II Expiration date on the patient label and date on the product carton were not the same. 26 Z-1276-2013