ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tiss
FDA device recall Z-1276-2013 · posted 2013-05-08 · Terminated
Recall details
- Recalling firm
- Medshape Solutions, INC.
- Reason for recall
- Expiration date on the patient label and date on the product carton were not the same.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 26
- Distribution
- Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
- Date initiated
- 2013-04-04
- Date posted
- 2013-05-08
- Date terminated
- 2013-08-07
- Location
- Atlanta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) (K111471) | Medshape Solutions, Inc. | 2011-06-10 |