Aesculap Implant Systems LLC AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
Brand
Aesculap Implant Systems LLC
Lot Codes / Batch Numbers
UDI-DI: 04038653362295
Products Sold
UDI-DI: 04038653362295
Aesculap Implant Systems LLC is recalling AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Us due to 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 micr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
An Urgent Medical Device Removal Notification issued September 08, 2020 sent via USPS certified mail. The notice identifies the affected part numbers S4C CROSS CONNECTOR SW112T, SW113T, SW114T, SW115T, SW116T and SW117T and asks distributors and customers to identify existing inventory, quarantine, and return affected inventory. If further distributed, identify and notify customers. The notice includes an acknowledgement form to be completed and returned to Aesculap Inc. via email at qa-recalls@aesculapusa.com. Questions are to be directed to Lindsay Chromiak, Manager, QA Compliance and Vigilance (610) 984-9072.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026