The Recall Desk
HighFDA (Devices)·Z-1444-2022·Announced 2022-07-27

Aesculap S4 Cervical Cross Connector Spinal Implant System Recalled for Clamping Failure

Aesculap Implant Systems is recalling the AESCULAP S4 Cervical Cross Connector (product code SWT113T) used in spinal fusion surgery. The connectors may not clamp properly onto rods, potentially causing movement and wear particles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a spinal implant component with insufficient clamping force, creating risk of harm through connector movement and microparticle abrasion. No injuries or hospitalizations have been reported, placing it in the High severity category as a risk-of-harm product without reported injury.

Plain-English summary

Aesculap Implant Systems is recalling the AESCULAP S4 Cervical Cross Connector L24mm (product code SWT113T), a component used in spinal fusion surgery. The product is a fixed 24mm cross connector that is part of a cervical spinal surgical system.

The recall was initiated because the cross connectors have insufficient clamping force. This defect may allow the connectors to move on the surgical rods and may cause microparticle abrasion in the surgical implant system.

The affected product was distributed nationwide in the following states: California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas, and Wyoming. A total of 24 units were distributed.

Healthcare facilities and surgeons who have this product in stock should stop using it immediately. Contact Aesculap Implant Systems LLC for instructions on replacement products or return procedures. If a patient has already had surgery with this implant, consult with your healthcare provider about monitoring for potential complications.

The recalled product

Product
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Orthopedic / Spinal Implant
Hazard
  • clamping-force-failure
  • connector-movement
  • microparticle-abrasion

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 04038653362301

Distribution

Distributed nationwide across the United States.

Related recalls

Same category