| | Class 2 Device Recall |  |
| Date Initiated by Firm | November 28, 2023 |
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| Date Posted | January 31, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0932-2024 |
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| Recall Event ID |
93748 |
| 510(K)Number | K222637 |
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| Product Classification |
Plate, fixation, bone - Product Code HRS
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| Product | 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. |
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| Code Information |
REF/UDI-DI/Lots: VBEAL-3-7N/00842188124907/ME23071, ME23072; VBEAL-5-7N/00842188124914/ME23073; VBEAL-3-7S/00842188124938/ME23031, ME23067, ME23082, ME23097; VBEAL-5-7S/00842188124945/ME23068; VBEAL-7-7S/00842188124952/ME23004, ME23086; VBEAL-3-7W/00842188124969/ME23033; VBEAL-5-7W/00842188124976/ME23036; VBEAR-3-7N/00842188124990/ME23069, ME23084, ME23085; VBEAR-5-7-N/00842188125003/ME23074; VBEAR-3-7S/00842188125027/ME23029, ME23087;
VBEAR-5-7S/00842188125034/ME23019; VBEAR-7-7S/00842188125041/ME23022; VBEAR-3-7W/00842188125058/ME23034; VBEAR-5-7W/00842188125065/ME23041, ME23037 |
Recalling Firm/
Manufacturer |
TriMed Inc.
27533 Avenue Hopkins
Santa Clarita CA 91355-3910
|
| For Additional Information Contact |
661-255-7406 |
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Manufacturer Reason
for Recall | Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes. |
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FDA Determined
Cause 2 | Labeling design |
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| 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. |
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| Quantity in Commerce | 270 |
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| Distribution | US: FL, MI, AL, NY, CA |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HRS
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