The Recall Desk
HighFDA (Devices)·Z-0932-2024·Announced 2024-02-07

Volar Bearing Plate wrist fixation systems recalled for bearing dislodgement

TriMed Inc. recalls Volar Bearing Plate wrist fixation systems because bearings may dislodge from distal peg holes during implantation, potentially compromising fracture fixation. Approximately 270 units distributed in five states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II medical device with a known mechanical defect (bearing dislodgement) that poses a risk to implant stability and fracture fixation. No injuries or deaths have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

TriMed Inc. is recalling Volar Bearing Plate wrist fixation systems intended to treat certain types of fractures, non-unions, and osteotomies. These devices include 14 product reference numbers in the VBEAL and VBEAR series.

Bearings in these plates may dislodge from distal peg holes during or after surgical implantation. This defect could compromise the mechanical integrity of the fixation system and its ability to maintain proper bone alignment and stability.

Approximately 270 affected units have been distributed across Florida, Michigan, Alabama, New York, and California. The recall encompasses 25 specific lot numbers associated with the affected reference models.

Patients who received these devices should contact their healthcare provider or TriMed Inc. to confirm whether they received an affected plate and to discuss any appropriate follow-up evaluation or monitoring.

The recalled product

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,
Manufacturer
TriMed Inc.
Category
Medical Device — Orthopedic Surgical Implant
Hazard
Affected units
270

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 5 states:

Related recalls

Same manufacturer · TriMed Inc.

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