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1.5mm System Plate 01-7135

by Biomet Microfixation, Inc

1.5mm System Plate 01-7135 is a Class II device made by Biomet Microfixation, Inc, cleared under FDA 510(k) K121589 on 21 Sep 2012 (1 earlier submission) and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036150716), active as of 23 Oct 2026. 4 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

9 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841036150716 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK121589 Date21 Sep 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121589 decided 21 Sep 2012 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00841036150716 listed 11 Oct 2015 Listed

Recalls

9 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-0835-2012 FDA Unclassified (pre-2012) initiated 8 Nov 2010 on shared 510(k) K953385
    • Terminated Z-0836-2012 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.

Timeline

12 dated events

  1. Recall initiated FDA recalls Z-1151-2010
  2. Recall initiated FDA recalls Z-2206-2010
  3. Recall initiated FDA recalls Z-1286-2012
  4. Recall initiated FDA recalls Z-2873-2011
  5. Recall initiated FDA recalls Z-2385-2011
  6. Recall initiated FDA recalls Z-0835-2012
  7. Recall initiated FDA recalls Z-0836-2012
  8. Cleared FDA 510(k) K121589
  9. Listed FDA GUDID 00841036150716
  10. Recall initiated FDA recalls Z-1220-2017

2 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
"1.5mm" System Plate
Generic name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Ref / Catalog
01-7135
Primary DI / UDI-DI
00841036150716
510(k) Number
FDA product code
JEY
GMDN term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device class
Class II
Regulation number
872.4760
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Craniofacial fixation plate, non-bioabsorbable, non-customized

Cleared under the same submission (K121589)

and 8 more cleared under K121589

Cleared under the same submission (K953385)

and 8 more cleared under K953385

Similar devices in this category

Other devices filed under Craniofacial fixation plate, non-bioabsorbable, non-customized.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)