Z-1443-2022 Class II Terminated
FDA device recall Z-1443-2022 was initiated by Aesculap Implant Systems LLC on September 8, 2020 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated April 10, 2024). Affected quantity: 24.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- September 8, 2020
- Termination Date
- April 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24
Product Description
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
Reason for Recall
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.
Distribution Pattern
United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
Code Information
UDI-DI: 04038653362295