FDA-Device2013-08-07Class II
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
SpineFrontier, Inc.
Hazard
Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.
Sold states
US distribution in states of: CO, DC, MA and TX.
Affected count
11 caddies
Manufactured in
500 Cummings Ctr Ste 3500, N/A, Beverly, MA, United States
Products
Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1869-2013Don't want to check this manually?
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