FDA (Devices) recall action 90502
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Aesculap Implant Systems is recalling the S4 Cervical Cross Connector L 33-42mm due to insufficient clamping force that may cause connector movement or microparticle abrasion in spinal fusion implants.
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.
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.
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.
Aesculap Implant Systems is recalling the AESCULAP S4 Cervical Cross Connector (product code SWT113T) used in spinal fusion surgery. The connectors may not clamp properly onto rods, potentially causing movement and wear particles.
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.