Device product
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
Z-1446-2022
Product summary
- Event
- Event 90502
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23
- Official record key
device-enforcement:Z-1446-2022
Official wording
Reason: 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.
Code information: UDI-DI: 04038653362325
Distribution pattern: United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
Derived failure modes
-
Unknown
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.