Home › CARBOFIX ORTHOPEDICS LTD › CarboClear Hybrid Pedicle Screw System
CarboClear Hybrid Pedicle Screw System
CARBOFIX ORTHOPEDICS LTD · Model Pedicle Screw - Dual Thread · UDI-DI 07290117355992
2
510(k) clearances
310
Adverse events (8 deaths)
2
Recalls
80
Facilities
Description
CarboClear Hybrid Dual Thread Pedicle Screw Solid
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.