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
- Hazard
- structural-defect
- implant-displacement
- wear-debris
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.
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