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SpineFrontier, Inc. recalls Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inser
Recalled June 12, 2013 · FDA recall Z-1482-2013 · SpineFrontier
Hazard
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet. · FDA Class II
Units
10
Sold at
Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
Description
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Product
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.
Manufacturer(s)
SpineFrontier, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →