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N/A Sp-1915

by Biomet Microfixation, Inc 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

11 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 Number00888233013956 UDI-DI Date16 Jun 2020ListedStatusListed GUDID: in commercial distribution

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

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Cranioplasty sheet
Model / Ref / Catalog
SP-1915
Primary DI / UDI-DI
00888233013956
510(k) Number
FDA Product Code
GXR, JEY, GWO, HBW
GMDN Term
Cranioplasty sheet
Device Class
Class II
Regulation Number
882.5250, 872.4760, 882.5320, 882.5360
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Cranioplasty sheet

Cleared under the same submission (K121589)

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Cleared under the same submission (K121624)

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Cleared under the same submission (K953385)

Show all (12)

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Sterile: 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