2.0mm System 01-2315

• EUDAMED Basic UDI-DI B-00841036008956 registered 23 Oct 2026 Active
• FDA 510(k) K121589 decided 21 Sep 2012 Active· +1 more in the status table
• FDA GUDID UDI-DI 00841036008956 listed 11 Oct 2015 Listed

• • 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.

1. 17 Mar 2010 Recall initiated FDA recalls Z-2206-2010
2. 26 Apr 2010 Recall initiated FDA recalls Z-1286-2012
3. 17 May 2010 Recall initiated FDA recalls Z-2873-2011
4. 28 Jul 2010 Recall initiated FDA recalls Z-2385-2011
5. 8 Nov 2010 Recall initiated FDA recalls Z-0835-2012
6. 8 Nov 2010 Recall initiated FDA recalls Z-0836-2012
7. 21 Sep 2012 Cleared FDA 510(k) K121589
8. 11 Oct 2015 Listed FDA GUDID 00841036008956
9. 10 Jan 2017 Recall initiated FDA recalls Z-1220-2017
10. 23 Oct 2026 Registered EUDAMED B-00841036008956

3 earlier events are in the sections above.

Trade name

"""2.0mm"" System" EUDAMED

"2.0mm" System GUDID

Generic name

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Model / Ref / Catalog

01-2315

Primary DI / UDI-DI

00841036008956

Basic UDI-DI

B-00841036008956

510(k) Number

K121589 ↗

K953385 ↗

FDA product code

JEY

EMDN code

P09120503 Osteosynthesis screw-plate systems

GMDN term

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Device class

Class IIb EUDAMED

Class II GUDID

Regulation number

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

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

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

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