The Recall Desk
HighFDA (Devices)·Z-1448-2022·Announced 2022-07-27

Cervical spinal implant connectors may fail to maintain proper clamping force

Aesculap Implant Systems has recalled certain cervical spine implant connectors due to insufficient clamping force. The defect may allow movement on the rods or cause microparticle abrasion.

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: The recall involves a Class II medical device with a structural defect in a spinal implant where mechanical failure could pose serious harm. However, no injuries or illnesses have been reported, consistent with the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Aesculap Implant Systems LLC is recalling AESCULAP S4 Cervical Cross Connector units (product code SW117T) used in cervical spinal fusion surgery. These connectors are designed to hold spinal rods in place during fusion procedures.

The recalled units have insufficient clamping force in the cross connectors. This defect may allow the connectors to move on the rods or cause microparticle abrasion.

The recall affects 27 units that were distributed nationwide to medical facilities 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 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Spinal Implant
Hazard
Affected units
27

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: 04038653362349

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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