Recall Z-0932-2024— TriMed Inc.

Name: FDA recall Z-0932-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-28

Class II · Ongoing

Class II FDA medical device recall by TriMed Inc., initiated 2023-11-28. It names one FDA 510(k) clearance: K222637. 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.. Reason: Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes..

Recalling firm: TriMed Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-28
Firm location: Santa Clarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K222637 — TriMed Wrist Fixation System 3TriMed, Inc.·cleared 2022-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.

Data sourced from openFDA. This site is unofficial and independent of the FDA.