The Recall Desk
HighFDA (Devices)·Z-1446-2022·Announced 2022-07-27

Cervical spinal implant connectors may have insufficient clamping force

Aesculap S4 Cervical Cross Connectors used in spinal fusion surgery may have insufficient clamping force, potentially causing movement of the connectors on the rods or wear debris.

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 a Class II medical device with a mechanical defect (insufficient clamping force) that presents a risk of implant displacement and wear debris in a high-risk anatomical location. The hazard is potential rather than confirmed, with no reported injuries, placing this in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Aesculap Implant Systems LLC is recalling the AESCULAP S4 Cervical Cross Connector L 28-33mm (model SW115T), a connector component used during cervical spinal fusion surgery to stabilize the spine.

The connectors have insufficient clamping force, which may allow the connectors to move on the rods during or after implantation. This movement or the associated wear may cause microparticle abrasion within the spinal surgical system.

The recall involves 23 units distributed to healthcare facilities nationwide in California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas, and Wyoming.

The recalled product

Product
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Orthopedic Spinal Implant
Hazard
Affected units
23

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: 04038653362325

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Aesculap Implant Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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