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Trimed, INC.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000014390 FEI 3001236812

Devices
3,162
Registrations
EUDAMEDFDA
FDA recalls
194 ongoing since 2021 (9 open in total)
5 open since before 2021

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls

What Trimed, INC. makes

Trimed, INC. manufactures orthopaedic bone screws, fixation plates, bone staples, bone pins, and implant impactors, all non-bioabsorbable and non-adjustable where specified. The company also produces reusable surgical instrument trays, drill guides, and screwdrivers for use in orthopaedic procedures.

These devices are classified as Class I and Class II medical devices and are listed in the FDA’s Unique Device Identification (fda_udi) system. Trimed, INC. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3,162

Newest first, rows 1-50 of 3,162

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Showing 1-50 of 3,162

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000014390
FDA FEI number
3001236812
DUNS number
138041277
EUDAMED status
Active
EUDAMED registered name
TriMed, Inc.
Registered address
27533, Avenue Hopkins, 91355, Santa Clarita, United States
Phone
+1 661 255 7406
PRRC contact
Divya Raghavi Nandakumar(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 27 Nov 2030

EUDAMED certificates (1)

SGS Belgium NV 1639 1 certificate

  • US25/00000499 Active Supplemented

    Quality management system EU MDR

    Issued
    23 Sep 2026
    Expires
    27 Nov 2030
    Reason
    Add device or group

FDA recalls19

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 19 recalls initiated by Trimed, INC., the earliest on 2016-08-29 and the most recent on 2024-03-19. By recorded status: 9 ongoing and 10 terminated. The reasons filed fall into these groups: sterility or contamination, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 14
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 1
  • 2024 2
  • 2025 0
  • 2026 0

1 initiated before 2017

Showing the 10 most recent of 19 recalls.

  • 2024

    • 19 Mar 2024 Z-1791-2024 Class II Ongoing Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque. Distribution: US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT,…
      Full distribution text US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI.
      Submission number: K234040
    • 19 Mar 2024 Z-1792-2024 Class II Ongoing Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque. Distribution: US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT,…
      Full distribution text US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI.
      Submission number: K234040

  • 2023

    • 28 Nov 2023 Z-0932-2024 Class II Ongoing 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 Submission number: K222637

  • 2022

    • 22 Dec 2022 Z-1101-2023 Class II Ongoing 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. Distribution: US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS Submission number: K220650

  • 2018

    • 28 Sep 2018 Z-0355-2020 Class II Open since 2018 The epoxy on Apex manufactured epoxy-coated instruments can pop off. Distribution: Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was…
      Full distribution text Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
    • 28 Sep 2018 Z-0356-2020 Class II Open since 2018 The epoxy on Apex manufactured epoxy-coated instruments can pop off. Distribution: Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was…
      Full distribution text Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
    • 28 Sep 2018 Z-0357-2020 Class II Open since 2018 The epoxy on Apex manufactured epoxy-coated instruments can pop off. Distribution: Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was…
      Full distribution text Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
    • 28 Sep 2018 Z-0358-2020 Class II Open since 2018 The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. Distribution: Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was…
      Full distribution text Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
    • 28 Sep 2018 Z-0359-2020 Class II Open since 2018 The WHD/WHV impactors can rust over time due to an improper manufacturing process. Distribution: Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was…
      Full distribution text Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.
    • 24 Aug 2018 Z-0118-2020 Class II Terminated 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. Distribution: Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia.…
      Full distribution text Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia. There was no government distribution.
      Submission number: K951302
Show all 19 recalls

  • 2018

    • 24 Aug 2018 Z-1214-2019 Class II Terminated The bone screw is shorter than the intended design specification. Distribution: US Distribution to states of FL and MO. Submission number: K060041
    • 15 Aug 2018 Z-0366-2020 Class II Terminated 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. Distribution: US Nationwide distribution in the states of MD, UT. Submission number: K060041
    • 16 Apr 2018 Z-2877-2018 Class II Terminated 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 Distribution: Worldwide Distribution in the state of TX and countries of Australia, China Sweden Submission number: K043263
    • 13 Apr 2018 Z-2262-2018 Class II Terminated 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 defined dose. There is a risk that this issue could result in patient infection if not properly sterilized. Distribution: U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden Submission number: K112794
    • 13 Apr 2018 Z-2263-2018 Class II Terminated 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 defined dose. There is a risk that this issue could result in patient infection if not properly sterilized. Distribution: U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden Submission number: K112794
    • 13 Apr 2018 Z-2264-2018 Class II Terminated 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 defined dose. There is a risk that this issue could result in patient infection if not properly sterilized. Distribution: U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden Submission number: K112794
    • 13 Apr 2018 Z-2265-2018 Class II Terminated 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 defined dose. There is a risk that this issue could result in patient infection if not properly sterilized. Distribution: U.S.: IL, UT, PA, NJ, WA, TX, NV, CA, NC, MS, KS, MO, MN, FL; OUS: Australia and Sweden Submission number: K112794
    • 11 Jan 2018 Z-1373-2018 Class II Terminated 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. Distribution: US, China, Latin America

  • 2016

    • 29 Aug 2016 Z-2849-2016 Class II Terminated 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. Distribution: Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California,…
      Full distribution text Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.
      Submission number: K060041

Frequently asked questions

How many devices does Trimed, INC. have in the registry?

The registry currently lists 3162 devices for Trimed, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Trimed, INC.'s devices?

Among its 50 most recently registered devices, Trimed, INC. has devices listed in FDA GUDID (50 devices).

What risk classes do Trimed, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Trimed, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Trimed, INC.?

FDA recall records list 19 recalls initiated by Trimed, INC., the most recent initiated on 19 Mar 2024. 9 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Trimed, INC.?

EUDAMED lists 1 certificate for Trimed, INC. (quality management system) under MDR. The most recent was issued on 23 Sep 2026.

What are the newest devices from Trimed, INC. in the registry?

The most recently registered devices listed for Trimed, INC. include CannCompScrew 5.5 (Ti) L5546 T, CannCompScrew 5.5 (Ti) L5554 T, CannCompScrew 5.5 (Ti) L5550 T and CannCompScrew 5.5 (Ti) L5558 T.

Generated automatically from registry data and not verified by a human reviewer.