Home › Device types › GWO
Plate, Cranioplasty, Preformed, Alterable
FDA product code GWO · Class 2 · Neurology
1,484
Registered devices
944
Adverse events
24
Recalls
43
510(k) clearances
Devices with this code
MatrixNEURO — Synthes GmbHRESORB XG, STERILE — KLS-Martin L.P.THINFLAP — BIOMET MICROFIXATION, INCTHINFLAP SYSTEM 5/PK — BIOMET MICROFIXATION, INCLeforte Neuro System Bone Plate — Jeil Medical CorporationNA — Stryker Leibinger GmbH & Co. KG1.5MM SYSTEM — BIOMET MICROFIXATION, INC1.5MM SYSTEM — BIOMET MICROFIXATION, INCRAAS Cranial Plating System — ALLIANCE PARTNERS LLC2.0MM SYSTEM — BIOMET MICROFIXATION, INCN/A — BIOMET MICROFIXATION, INCRESORB XG, STERILE — KLS-Martin L.P."2.0MM" SYSTEM — BIOMET MICROFIXATION, INC1.5MM SYSTEM — BIOMET MICROFIXATION, INCStarPore — ANATOMICS PTY LTD1.5MM SYSTEM — BIOMET MICROFIXATION, INC1.5MM SYSTEM — BIOMET MICROFIXATION, INC"2.0MM" SYSTEM PLATE — BIOMET MICROFIXATION, INC"2.0MM" SYSTEM — BIOMET MICROFIXATION, INCLeforte Neuro System Bone Plate — Jeil Medical CorporationRAAS Cranial Plating System — ALLIANCE PARTNERS LLCOsteoMed — OSTEOMED LLCMatrixNEURO — Synthes GmbHCMF SYSTEM — BIOMET MICROFIXATION, INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-29 | Stryker Leibinger GmbH & Co. KG | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure |
| 2023-05-31 | Osteomed, LLC | Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. |
| 2023-05-31 | Osteomed, LLC | Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. |
| 2018-06-22 | Stryker Leibinger GmbH & Co. KG | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. |
| 2018-06-22 | Stryker Leibinger GmbH & Co. KG | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. |
| 2018-06-22 | Stryker Leibinger GmbH & Co. KG | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. |
| 2018-06-22 | Stryker Leibinger GmbH & Co. KG | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. |
| 2018-06-22 | Stryker Leibinger GmbH & Co. KG | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. |
| 2018-06-22 | Stryker Leibinger GmbH & Co. KG | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. |
| 2018-06-22 | Stryker Leibinger GmbH & Co. KG | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. |
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