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OIC Variable Angle Small Fragment Locking Plate System
ORTHOPAEDIC IMPLANT COMPANY, THE · Model ST-3575 · UDI-DI 10811998035366
HWC
Prescription
1
510(k) clearances
58,622
Adverse events (75 deaths)
388
Recalls
655
Facilities
Description
3.5MM X 75MM CORTEX SCREW
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-24 | Medartis AG | The cannulation of the CCS screw is not centered. |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| 2026-01-23 | I.T.S. GmbH | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2026-01-09 | Medartis AG | Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. |
| 2025-11-24 | Smith & Nephew, Inc. | Removal of affected lot of screws due to labeling error. |
| 2024-04-12 | Medartis Inc. | Screw is 16mm long instead of 22mm long. |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
| 2024-03-20 | Zimmer, Inc. | Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user sinc |
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