FDA Device Intelligence
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Appliance, Fixation, Spinal Intervertebral Body

FDA product code KWQ · Class 2 · Orthopedic

171,142
Registered devices
10,554
Adverse events
214
Recalls
667
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-02-20Clariance-SASDue to a quality issue regarding the presence of burr on the finished cervical plate product.
2021-04-26Alphatec Spine, Inc.There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope
2021-04-26Alphatec Spine, Inc.There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope
2021-04-26Alphatec Spine, Inc.There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope
2021-04-26Alphatec Spine, Inc.There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope
2021-04-26Alphatec Spine, Inc.There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope
2021-04-26Alphatec Spine, Inc.There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope
2021-04-26Alphatec Spine, Inc.There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope
2021-04-26Alphatec Spine, Inc.There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope
2021-04-26Alphatec Spine, Inc.There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postope

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.