Home › MET 1 TECHNOLOGIES, LLC › CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL
CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL
MET 1 TECHNOLOGIES, LLC · Model 60010014 · UDI-DI 00819824024136
KWQ
Prescription
1
510(k) clearances
10,554
Adverse events (59 deaths)
214
Recalls
359
Facilities
Description
THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATION OF THE CERVICAL SPINE. THE SYSTEM INCLUDES SCREWS, PLATES, AND A SET OF INSTRUMENTS TO INSERT THE IMPLANTS. PLATES ARE AVAILABLE IN A VARIETY OF LENGTHS TO ACCOMODATE FUSION PROCEDURES FROM ONE TO FOUR LEVELS OF THE CERVICAL SPINE. FIXATION IS ACHIEVED BY INSERTING THE SCREWS THROUGH THE OPENINGS IN THE PLATE INTO VERTEBRAL BODIES OF THE CERVICAL SPINE. THE PLATES ARE MANUFACTURED FROM TITANIUM 6 A1-4V ELI PER ASTM F136 AND INVIBIO PEEK-OPTIMA LT1 PER ASTM F2026.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-20 | Clariance-SAS | Due to a quality issue regarding the presence of burr on the finished cervical plate product. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
| 2021-04-26 | Alphatec Spine, Inc. | There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively. |
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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.
