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Aesculap Implant Systems LLC Recall 90502

Description: AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.

Aesculap Implant Systems LLC Recall 90502 Information

StatusCompleted
Mandated?Voluntary: Firm initiated
Recall NumberZ-1444-2022
Event ID90502
Event DescriptionAESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Product TypeDevices
DistributionUnited States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
Quantity24
Recall ReasonInsufficient 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.
Device Classification20220727
Device Code InfoUDI-DI: 04038653362301
Center Classification Date20220721
Recall Initiation Date20200908
Recalling FirmAesculap Implant Systems LLC
Initial Notification Letter
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