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Trauma Fixation Systems 14-441054

by Biomet Orthopedics, Inc.

Ref 14-441054

Trauma Fixation Systems 14-441054 is a device classified as Class IIa in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI B-00887868470691), cleared under FDA 510(k) K831005 on 18 May 1983 and listed in FDA GUDID since 19 Mar 2022 (UDI-DI 00887868470691), active as of 7 Nov 2026. 15 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

15 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K831005

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00887868470691 Basic UDI-DI 00887868470691UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868470691 UDI-DI Date19 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK831005 Date18 May 1983DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00887868470691 registered 24 Oct 2026 Active
  • FDA 510(k) K831005 decided 18 May 1983 Active
  • FDA GUDID UDI-DI 00887868470691 listed 19 Mar 2022 Listed

Recalls

15 recalls · FDA

  • 13 recalls, same reason

    • Terminated Z-2231-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2241-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2240-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2242-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2235-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2234-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2233-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2236-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2239-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2237-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2238-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2230-2018 FDA Class II initiated 16 May 2018
    • Terminated Z-2232-2018 FDA Class II initiated 16 May 2018

    The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires packaged in the affected packaging configuration have the potential for sterile barrier breach, leading to possible risk for infection.

    • Terminated Z-0087-2017 FDA Class II initiated 2 Aug 2016

    The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been packaged incorrectly either with two (2) 467265-01 Ball Tip Guide Pins and zero (0) 467255-02 Plain Tip Guide Pins or with zero (0) 467265-01 Ball Tip Guide Pins and two (2) 467255-02 Plain Tip Guide Pins. If the G-PIN 2.8BL 3.2PL 60 CM 2PK contains the incorrect combination of Plain Tip Guide Pins and Ball Tip Guide Pins, the surgeon would either have to implant the nail without the Plain Tip Guide Pin as a guide, ream with a Plain Tip Guide Pin, or choose to not ream the humeral canal. The risk associated with not having the correct combination can include a delay in surgery of less than 30 minutes, the reamer tip remaining in the distal humeral canal, or an iatrogenic fracture.

    • Terminated Z-1822-2016 FDA Class II initiated 1 Apr 2016

    Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Timeline

18 dated events

  1. Recall initiated FDA recalls Z-2234-2018
  2. Recall initiated FDA recalls Z-2233-2018
  3. Recall initiated FDA recalls Z-2236-2018
  4. Recall initiated FDA recalls Z-2239-2018
  5. Recall initiated FDA recalls Z-2237-2018
  6. Recall initiated FDA recalls Z-2238-2018
  7. Recall initiated FDA recalls Z-2230-2018
  8. Recall initiated FDA recalls Z-2232-2018
  9. Listed FDA GUDID 00887868470691
  10. Registered EUDAMED B-00887868470691

8 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Trauma Fixation Systems
Generic name
Orthopaedic bone wire
Model / Ref / Catalog
14-441054
Primary DI / UDI-DI
00887868470691
Basic UDI-DI
B-00887868470691
510(k) Number
FDA product code
HTY
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic bone wire
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic bone wire

Cleared under the same submission (K831005)

and 8 more cleared under K831005

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)