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CarboClear X Pedicle Screw System
CARBOFIX ORTHOPEDICS LTD · Model Pedicle Screw - Fenestrated · UDI-DI 07290117350331
10
510(k) clearances
310
Adverse events (8 deaths)
2
Recalls
80
Facilities
Description
Fenestrated pedicle screw (oncology)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-28 | Icotec Ag | icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected th |
| 2023-11-28 | Icotec Ag | icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected th |
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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.