# 2.0 System 95-2019T

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/2-0-system-95-2019t>
- Manufacturer: [Biomet Microfixation, Inc](https://devicerts.com/manufacturers/biomet-microfixation-inc) (United States)
- Name in the registry: 2.0 SYSTEM 95-2019T
- Device class: Class IIb (EU MDD); Class II (US FDA)
- FDA product code: JEY
- EMDN: P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS
- GMDN: Orthopaedic bone screw, non-bioabsorbable, non-sterile (56642)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-00841036056377 · UDI-DI 00841036056377 · registered 2026-10-27 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 00841036056377 · listed 2015-10-11 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K121589 · decision 2012-09-21 · decision SESE · status: Active · from GUDID
- **GUDID** · FDA 510(k) · United States · K953385 · decision 1995-09-28 · decision SESE · status: Active · from GUDID

## Recalls

- Z-1220-2017 · Class II · terminated · initiated 2017-01-10 · matched through shared submission K121589, may concern other models: The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
- Z-0835-2012 ·  · terminated · initiated 2010-11-08 · matched through shared submission K953385, may concern other models: 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
- Z-0836-2012 ·  · terminated · initiated 2010-11-08 · matched through shared submission K953385, may concern other models: 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
- Z-2385-2011 ·  · terminated · initiated 2010-07-28: 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).
- Z-2873-2011 ·  · terminated · initiated 2010-05-17 · matched through shared submission K953385, may concern other models: 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.
- Z-1286-2012 ·  · terminated · initiated 2010-04-26: 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.
- Z-2206-2010 ·  · terminated · initiated 2010-03-17 · matched through shared submission K953385, may concern other models: 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.
- Z-1151-2010 ·  · terminated · initiated 2009-10-06: 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.
- Z-1943-2010 ·  · terminated · initiated 2009-10-05: 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.

## Identity

- Trade name: 2.0 SYSTEM [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Orthopaedic bone screw, non-bioabsorbable, non-sterile [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 95-2019T [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00841036056377 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-00841036056377 [EUDAMED]
- 510(k) Number: K121589 [FDA GUDID (AccessGUDID)]; K953385 [FDA GUDID (AccessGUDID)]
- FDA product code: JEY [FDA GUDID (AccessGUDID)]
- EMDN code: P09120503 [EUDAMED]
- GMDN term: Orthopaedic bone screw, non-bioabsorbable, non-sterile (56642) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 872.4760 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Netherlands [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Implantable: Yes [EUDAMED]; No [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: 2.0 System 95-2019T, Biomet Microfixation, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/2-0-system-95-2019t (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-11-07
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/2-0-system-95-2019t.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/2-0-system-95-2019t
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.