FDASeptember 8, 2020device
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
aesculap implant systemsaesculapaesculap implant
UPCs
04038653362349
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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