Recall Z-0932-2024 ยท HRS Plate, Fixation, Bone
TriMed Inc.
Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies.
| Date | Jan 31, 2024 (initiated Nov 28, 2023) |
| Status | Open, Classified |
| Reason | Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes. |
| Root cause | Labeling design |
| Action | On 11/28/23, recall notices were emailed to customers who were asked to do the following: 1) Stop further use of the device and return any unused products to the recalling firm. 2) Provide a copy of this recall notice to the hospital/surgeon/physician that is using the device. 3) Complete and return the response form to quality@trimedortho.com Contact quality@trimedortho.com for any additional questions. |
| Quantity | 270 |
| Distribution | US: FL, MI, AL, NY, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222637 | TriMed Wrist Fixation System 3 TriMed, Inc., Dec 21, 2022 |