FDA-Device2013-06-12Class II
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
SpineFrontier, Inc.
Hazard
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Sold states
Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
Affected count
10
Manufactured in
500 Cummings Ctr Ste 3500, N/A, Beverly, MA, United States
Products
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1482-2013Don't want to check this manually?
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