Device recall
Z-1276-2013: ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the…
FDA device recall · Class II · Medshape Solutions, INC.
Key facts
| Recall number (Z-number) | Z-1276-2013 |
|---|---|
| Recall event | 64988 |
| 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. |
| Product code | MBI |
| Recalling firm | Medshape Solutions, INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2013 |
| 510(k) numbers | K111471 |
| FEI number | 3007593722 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database