TRIMED, INC.

Activity by year

Devices registered here (2)

• Screw, Fixation, Bone
  Product code HWC (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040
• Plate, Fixation, Bone
  Product code HRS (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030

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.

FDA inspections (5)

• VAI2024-06-03
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• NAI2019-08-14
  No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
• NAI2017-11-17
  No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• VAI2017-01-12
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• OAI2016-03-18
  Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

• Warning Letter2016-06-30
  Warning Letter (opens in a new tab) · Valencia California

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

• All facilities operated by TRIMED, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)