Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.
worldwide Distribution - US Distribution to the states of : CA, FL, MO, NC, SC, TX, and WI., and to the countries of : Argentina, China, Colombia, Germany, Japan, Netherlands, South Africa, Thailand, and Vietnam.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1705-2018