Device 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.
Z-1276-2013
Product summary
- Event
- Event 64988
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26
- Official record key
device-enforcement:Z-1276-2013
Official wording
Reason: Expiration date on the patient label and date on the product carton were not the same.
Code information: Lot No. 113011-002
Distribution pattern: Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
Derived failure modes
-
Unknown
Expiration date on the patient label and date on the product carton were not the same.