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Class II recall issued for Aesculap instruments used with A-Space SIBD, Arcadius XP L systems
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A class II recall was recently issued for all lots of Aesculap Implant Systems’ flexible screw driver (SJ706R), flexible bone awl (SJ607R) and flexible drill (SJ723R) intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems, according to an FDA release.
According to the release, the recall is due to possible breakage of the flexible shaft of the instruments during surgery which may cause a “risk of a delay in surgery or that a fragment from the shaft could be left in the patient.” At the time of the release, there had been 18 reports of breakages during surgery.
In the release, owners of the instruments were instructed not to destroy the products, but rather immediately remove and return the instruments, and “use the ‘U’ joint screwdriver, ME014R in place of the SJ706R of which is already part of set ST0485.”
References:
Class 2 recall ASpace SIBD and Arcadius XP L systems. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142314. Accessed: Dec. 18, 2015.
Class 2 recall ASpace SIBD and Arcadius XP L systems. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142313. Accessed: Dec. 18, 2015.
Class 2 recall ASpace SIBD and Arcadius XP L systems. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141790. Accessed: Dec. 18, 2015.