FDA recall Z-0932-2024

TriMed Inc. · Class II · device

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 for recall

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

Distribution

US: FL, MI, AL, NY, CA

Key facts

Status
Ongoing
Initiation date
2023-11-28
Report date
2024-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0932-2024