Recall Z-0118-2020 ยท HRS Plate, Fixation, Bone
TriMed Inc.
TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.
| Date | Oct 10, 2019 (initiated Aug 24, 2018) |
| Status | Terminated |
| Reason | Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device. |
| Root cause | Device Design |
| Action | The recalling firm issued letters via email on 8/24/2018 informing the distributor of the medical facility of the issue. The distributor is then responsible for notifying the medical facility to whom the device is invoiced. |
| Quantity | 5 devices |
| Distribution | Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia. There was no government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951302 | SMALL FRAGMENT PLATES AND SCREWS Medpac, May 5, 1995 |