RegWardenFDA facility compliance records
Company

TRIMED, INC.

11 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2016: 1 recalls; 2018: 7 recalls; 2022: 1 recalls; 2023: 1 recalls; 2024: 1 recalls1201620177201820192020202112022120231202420252026
  • Recalls (11)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-03-19
    Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
  • Class IIOngoing2023-11-28
    Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
  • Class IIOngoing2022-12-22
    Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
  • Class IIOngoing2018-09-28
    The WHD/WHV impactors can rust over time due to an improper manufacturing process.
  • Class IITerminated2018-08-24
    The bone screw is shorter than the intended design specification.
  • Class IITerminated2018-08-24
    Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.
  • Class IITerminated2018-08-15
    The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.
  • Class IITerminated2018-04-16
    Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate
  • Class IITerminated2018-04-13
    During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the …
  • Class IITerminated2018-01-11
    Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.
  • Class IITerminated2016-08-29
    TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “TRIMED, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9031076-trimed-inc/

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