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AccelFix Spinal Fixation System
L&K BIOMED CO. ,LTD. · Model 8114-8045 · UDI-DI 08800061377651
1
510(k) clearances
10,554
Adverse events (59 deaths)
214
Recalls
359
Facilities
Description
Reduction Poly Axial Screw Ø8.0 , 45mm
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.