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Plate, Bone
FDA product code JEY · Class 2 · Dental
0
Registered devices
10,594
Adverse events
111
Recalls
294
510(k) clearances
Devices with this code
TiMesh® — MEDTRONIC PS MEDICAL, INC.MatrixMANDIBLE — Synthes GmbHTRAUMAONE SYSTEM — BIOMET MICROFIXATION, INCN/A — BIOMET MICROFIXATION, INC2.0 SYSTEM — BIOMET MICROFIXATION, INCLEVEL ONE CMF, STERILE — KLS-Martin L.P.LEVEL ONE CMF — KLS-Martin L.P.NA — Stryker Leibinger GmbH & Co. KGMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftCRANIOPLATE — Aesculap AGACR Bone Screw — BioMaterials Korea, Inc.MatrixMANDIBLE — Synthes GmbHNA — Stryker Leibinger GmbH & Co. KGLEVEL ONE CMF — KLS-Martin L.P.N/A — BIOMET MICROFIXATION, INCNA — Stryker Leibinger GmbH & Co. KGNA — Stryker Leibinger GmbH & Co. KGNA — SYNTHES (U.S.A.) LPLEVEL ONE CMF, STERILE — KLS-Martin L.P.AccuPlan System — Medcad2.0 SYSTEM — BIOMET MICROFIXATION, INC2.0 SYSTEM — BIOMET MICROFIXATION, INCLEVEL ONE NEURO — KLS-Martin L.P.LEVEL ONE NEURO, STERILE — KLS-Martin L.P.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-06-19 | Materialise N.V. | Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request |
| 2020-11-25 | Biomet, Inc. | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the d |
| 2020-06-18 | Synthes, Inc. | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm scr |
| 2020-06-16 | Synthes Produktions GmbH | One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should hav |
| 2020-02-03 | Materialise N.V. | Custom surgical kits contain a plate different than indicated by the package labeling. |
| 2020-02-03 | Materialise N.V. | Custom surgical kits contain a plate different than indicated by the package labeling. |
| 2018-04-05 | Zimmer Biomet, Inc. | The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfe |
| 2016-05-02 | Synthes (USA) Products LLC | Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. |
| 2016-05-02 | Synthes (USA) Products LLC | Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. |
| 2016-05-02 | Synthes (USA) Products LLC | Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents. |
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