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Terminated

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

FDA Recall Z-1444-2022 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeNKB
Date Initiated2020-09-08
Date Terminated2024-04-10
Product Quantity24

Reason for Recall

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.

Firm Action

An Urgent Medical Device Removal Notification issued September 08, 2020 sent via USPS certified mail. The notice identifies the affected part numbers S4C CROSS CONNECTOR SW112T, SW113T, SW114T, SW115T, SW116T and SW117T and asks distributors and customers to identify existing inventory, quarantine, and return affected inventory. If further distributed, identify and notify customers. The notice includes an acknowledgement form to be completed and returned to Aesculap Inc. via email at [email protected]. Questions are to be directed to Lindsay Chromiak, Manager, QA Compliance and Vigilance (610) 984-9072.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062012S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEMAesculap, Inc. · 2007-02-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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