The Recall Desk
HighFDA (Devices)·Z-1447-2022·Announced 2022-07-27

Aesculap S4 Cervical Cross Connector Recalled Due to Clamping Force Defect

Aesculap Implant Systems is recalling the S4 Cervical Cross Connector L 33-42mm due to insufficient clamping force that may cause connector movement or microparticle abrasion in spinal fusion implants.

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 FDA Class II device recall involves a risk-of-harm condition—mechanical defect with potential for implant movement and microparticle generation—but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without documented injury receive a Score 3.

Plain-English summary

Aesculap Implant Systems LLC is recalling the AESCULAP S4 Cervical Cross Connector L 33-42mm (product code SW116T), a medical device used in cervical spinal fusion surgery. The device has an insufficient clamping force that may lead to movement of the connectors on the rods and/or microparticle abrasion.

This recall affects 20 units that were distributed nationwide in the United States to the states of California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas, and Wyoming. The device is identified by UDI-DI 04038653362332.

Surgeons and healthcare facilities that have received this product should contact Aesculap Implant Systems LLC for further guidance. Patients with the recalled implant should consult with their healthcare provider regarding whether replacement or additional monitoring is necessary.

The recalled product

Product
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Orthopedic Implant / Spinal Fusion
Hazard
  • mechanical-defect
  • implant-loosening
  • microparticle-generation

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: 04038653362332

Distribution

Distributed nationwide across the United States.

Related recalls

Same category