The Recall Desk
HighFDA (Devices)·Z-1443-2022·Announced 2022-07-27

Spinal Fusion Implant Cross Connectors Recalled for Insufficient Clamping Force

Aesculap is recalling its S4 Cervical Cross Connector used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to move on the rods or shed 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 of a high-risk spinal implant with potential for mechanical failure and particulate shedding. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).

Plain-English summary

Aesculap Implant Systems LLC is recalling the AESCULAP S4 Cervical Cross Connector L22mm (product code SW112T). This is a medical implant used to stabilize the spine during cervical fusion surgery.

The company is recalling the product because the cross connectors may have insufficient clamping force. This deficiency may cause the connectors to move on the rods during or after surgery, or may result in microparticle abrasion as the components shift.

The affected implants were distributed nationwide in California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas, and Wyoming. Approximately 24 units are affected (UDI-DI: 04038653362295).

If you have received or implanted this device, contact Aesculap Implant Systems LLC or the FDA with any questions or to report any adverse events related to this implant.

The recalled product

Product
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Spinal Implant
Hazard
  • mechanical-failure
  • connector-loosening
  • particulate-shedding

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: 04038653362295

Distribution

Distributed nationwide across the United States.

Related recalls

Same category