VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
FDA device recall Z-0728-2023 · posted 2022-12-19 · Open, Classified
Recall details
- Recalling firm
- Icotec Ag
- Reason for recall
- During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.
- Action taken
- Icotec issued a Field Action Notice to its consignee on 11/03/2022 by email. The notice explained the issue and that XXXX. The firm followed with an email to inform the consignee of their intent to recall the device. The notice requested the return of the device from the field. The firm will be replacing the devices.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- NKB
- Quantity affected
- 6 devices
- Distribution
- US Nationwide distribution in the state of GA.
- Date initiated
- 2022-11-03
- Date posted
- 2022-12-19
- Location
- Altstatten Sg, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| G21 Cement, VADER® Pedicle System (K200596) | Icotec AG | 2020-10-13 |
| VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K193423) | Icotec AG | 2020-05-22 |
| VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545) | Icotec AG | 2019-06-20 |