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N/A 01-0302

by Biomet Microfixation, Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

15 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841036007386 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution

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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Orthopaedic bone wire
Model / Ref / Catalog
01-0302
Primary DI / UDI-DI
00841036007386
510(k) Number
FDA Product Code
HTY
GMDN Term
Orthopaedic bone wire
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone wire

Cleared under the same submission (K831005)

Show all (12)

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No