Recall Z-1445-2022
Aesculap Implant Systems LLC · initiated September 8, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
Codes / lots: UDI-DI: 04038653362318
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1445-2022
- Initiated
- September 8, 2020
- Terminated
- April 10, 2024
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 24
- Distribution
- United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.
- Recalling firm
- Aesculap Implant Systems LLC, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1443-2022 Class II | AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | 09/08/2020Terminated |
| Z-1444-2022 Class II | AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | 09/08/2020Terminated |
| Z-1446-2022 Class II | AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | 09/08/2020Terminated |
| Z-1447-2022 Class II | AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | 09/08/2020Terminated |
| Z-1448-2022 Class II | AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM…Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement… | 09/08/2020Terminated |