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External Distraction System 99-5918

by Biomet Microfixation, Inc

External Distraction System 99-5918 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K831005 on 18 May 1983 and listed in FDA GUDID since 25 Nov 2015 (UDI-DI 00841036070885), active as of 23 Oct 2026. 15 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 closed

Documents

510(k) K831005

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841036070885 UDI-DI Date25 Nov 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK831005 Date18 May 1983DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K831005 decided 18 May 1983 Active
  • FDA GUDID UDI-DI 00841036070885 listed 25 Nov 2015 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

17 dated events

  1. Recall initiated FDA recalls Z-2242-2018
  2. Recall initiated FDA recalls Z-2235-2018
  3. Recall initiated FDA recalls Z-2234-2018
  4. Recall initiated FDA recalls Z-2233-2018
  5. Recall initiated FDA recalls Z-2236-2018
  6. Recall initiated FDA recalls Z-2239-2018
  7. Recall initiated FDA recalls Z-2237-2018
  8. Recall initiated FDA recalls Z-2238-2018
  9. Recall initiated FDA recalls Z-2230-2018
  10. Recall initiated FDA recalls Z-2232-2018

7 earlier events are in the sections above.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
External Distraction System
Generic name
Orthopaedic bone wire
Model / Ref / Catalog
99-5918
Primary DI / UDI-DI
00841036070885
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
Sterilisation method
Moist Heat or Steam Sterilization

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 bone wire.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)