Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CO
Recalled Product
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
Hazard / Issue
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Issued by
FDA
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