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Neuro Plating System
OSTEONIC CO.,Ltd. · Model TCN-012 · UDI-DI 08809595972882
1
510(k) clearances
953
Adverse events
24
Recalls
35
Facilities
Description
5 x straight 2 hole plates 15.4mm + 5 self tapping screws Ø1.5 x 4.0mm + 5 self drilling screws Ø1.5 x 4.0mm
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.