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
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1444-2022 |
| Event ID | 90502 |
| Event Description | AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery. |
| Product Type | Devices |
| Distribution | United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY. |
| Quantity | 24 |
| Recall 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. |
| Device Classification | 20220727 |
| Device Code Info | UDI-DI: 04038653362301 |
| Center Classification Date | 20220721 |
| Recall Initiation Date | 20200908 |
| Recalling Firm | Aesculap Implant Systems LLC |
| Initial Notification | Letter |
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