The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1445-2022·Announced 2022-07-27

Spinal fusion cross connector recalled for insufficient clamping force

Aesculap is recalling AESCULAP S4 Cervical Cross Connectors used in spinal fusion surgery due to insufficient clamping force that may cause the connectors to loosen or shift on the spinal rods.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II medical device with a mechanical failure (insufficient clamping force) in a critical spinal fusion component. Classified as a risk-of-harm product where no injuries have yet been reported, but potential consequences of connector loosening during or after spinal surgery could be serious.

Plain-English summary

Aesculap Implant Systems LLC is recalling the AESCULAP S4 Cervical Cross Connector, model L26mm (product code SW114T), a component used during cervical spine fusion surgery to stabilize spinal implants.

The connectors have insufficient clamping force, which may allow them to loosen or shift position on the spinal rods. This could potentially lead to movement of the device or microparticle abrasion from the connector rubbing against the rods. No injuries or illnesses have been reported to date.

The recalled devices were distributed nationwide in California, Colorado, Illinois, Indiana, Michigan, North Carolina, Nevada, Ohio, Pennsylvania, South Carolina, Texas, and Wyoming. A total of 24 units were affected.

Patients who have had this device implanted as part of spinal fusion surgery should contact their healthcare provider or Aesculap Implant Systems LLC to discuss their individual situation and any necessary follow-up.

The recalled product

Product
AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Spinal Fusion / Orthopedic
Hazard
Affected units
24

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: 04038653362318

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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