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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

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

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 Letter
Distribution Pattern Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.