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2.0mm System 91-6205

by Biomet Microfixation, Inc

Ref 91-6205

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

11 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121624

+2 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841036053789 Basic UDI-DI 00841036053789UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841036053789 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121624 Date12 Oct 2012DecidedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

11 recalls · FDA

    • Terminated Z-1220-2017 FDA Class II initiated 10 Jan 2017 on shared 510(k) K121589

    The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.

  • 2 recalls, same reason

    • Terminated Z-0137-2016 FDA Class II initiated 6 Aug 2015
    • Terminated Z-0136-2016 FDA Class II initiated 6 Aug 2015

    The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

  • 2 recalls, same reason

    • Terminated Z-0836-2012 FDA Unclassified (pre-2012) initiated 8 Nov 2010 on shared 510(k) K953385
    • Terminated Z-0835-2012 FDA Unclassified (pre-2012) initiated 8 Nov 2010 on shared 510(k) K953385

    On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes

    • Terminated Z-2385-2011 FDA Unclassified (pre-2012) initiated 28 Jul 2010

    Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6 Hold Long Double Y).

    • Terminated Z-2873-2011 FDA Unclassified (pre-2012) initiated 17 May 2010 on shared 510(k) K953385

    On May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some packages of 91-6704 lot 173770 are labeled as cross drive screws, but contain center drive screws. All affected customers were notified of the recall on May 17, 2010.

    • Terminated Z-1286-2012 FDA Unclassified (pre-2012) initiated 26 Apr 2010

    On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly.

    • Terminated Z-2206-2010 FDA Unclassified (pre-2012) initiated 17 Mar 2010 on shared 510(k) K953385

    Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.

    • Terminated Z-1151-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009

    Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.

    • Terminated Z-1943-2010 FDA Unclassified (pre-2012) initiated 5 Oct 2009

    Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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
"""2.0mm"" System" EUDAMED
"2.0mm" System GUDID
Generic name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / Ref / Catalog
91-6205
Primary DI / UDI-DI
00841036053789
Basic UDI-DI
B-00841036053789
510(k) Number
FDA product code
GXR, HBW, GWO, JEY
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.5250, 882.5360, 882.5320, 872.4760
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

Cleared under the same submission (K121589)

Show all (12)

Cleared under the same submission (K121624)

Show all (12)

Cleared under the same submission (K953385)

Show all (12)

Other devices from Biomet Microfixation, Inc

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Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number

Other properties (20)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: 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