Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion…

Recall date

September 8, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1444-2022

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.