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, VBEA

Hazard

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

Details from the source

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 Quantity: 270 Lot/code info: 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

UPC codes

00842188124907, 00842188124914, 00842188124938, 00842188124945, 00842188124952, 00842188124969, 00842188124976, 00842188124990, 00842188125003, 00842188125027, 00842188125034, 00842188125041, 00842188125058, 00842188125065

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.