Recall Z-1276-2013 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Medshape Solutions, INC.
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.
| Date | May 8, 2013 (initiated Apr 4, 2013) |
| Status | Terminated |
| Reason | Expiration date on the patient label and date on the product carton were not the same. |
| Root 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 | 26 |
| Distribution | Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111471 | EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) Medshape Solutions, Inc., Jun 10, 2011 |