Recall Z-0599-2020 ยท HRS Plate, Fixation, Bone
Toby Orthopaedics, Inc.
PANTERA Proximal Humerus Fracture Plate System
| Date | Jun 5, 2013 |
| Status | Terminated |
| Reason | Potential suture clip breaking during a humerus fixation surgery. |
| Root cause | Labeling design |
| Action | Beginning on 06/05/2013 the firm notified their direct consignees of the change in the instructions for use (IFU). On 10/11/2019, the firm followed up with the direct accounts (distributors) to reach out to the users to inform them of the change. |
| Quantity | 1700 devices |
| Distribution | Arkansas, Florida, Puerto Rico, Spain, Panama, Australia, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081608 | PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS) Toby Orthopaedics, LLC, Dec 19, 2008 |