Home › Device types › JEY
Plate, Bone
FDA product code JEY · Class 2 · Dental
13,566
Registered devices
10,393
Adverse events
111
Recalls
293
510(k) clearances
Devices with this code
SMARTLOCK — Stryker Leibinger GmbH & Co. KGMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftNA — Stryker Leibinger GmbH & Co. KGNA — Synthes GmbHNA — Synthes GmbHFAICO CMF System — FAICO MEDICAL LLCFAICO CMF System — FAICO MEDICAL LLCMatrixNEURO — Synthes GmbHMatrixMANDIBLE — Synthes GmbHRESORB X, STERILE — KLS-Martin L.P.LEVEL ONE NEURO, STERILE — KLS-Martin L.P.Bioplate® — Bioplate, Inc.OsteoMed — OSTEOMED LLCBioplate® — Bioplate, Inc.THINFLAP — BIOMET MICROFIXATION, INC1.5MM SYSTEM — BIOMET MICROFIXATION, INCN/A — BIOMET MICROFIXATION, INCInion instrument — Inion Oy2.5 mm Inion CPS® — Inion OyMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftTHINFLAP SYSTEM 5/PK — BIOMET MICROFIXATION, INCMatrixMIDFACE — Synthes GmbHLEVEL ONE CMF — KLS-Martin L.P.LEVEL ONE CMF — 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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