Z-1276-2013 Class II Terminated
FDA device recall Z-1276-2013 was initiated by Medshape Solutions, INC. on April 4, 2013 and is designated Class II. Reason for recall: Expiration date on the patient label and date on the product carton were not the same. The recall status is terminated (terminated August 7, 2013). Affected quantity: 26.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2013
- Initiation Date
- April 4, 2013
- Termination Date
- August 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
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.
Reason for Recall
Expiration date on the patient label and date on the product carton were not the same.
Distribution Pattern
Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
Code Information
Lot No. 113011-002