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Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spin
Recalled July 27, 2022 · FDA recall Z-1447-2022 · Aesculap Implant Systems
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. · FDA Class II
Units
20
Sold at
United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
Description
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.
Product
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →