Product Wiki · Recalls · U.S. FDA — Device Enforcement

AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery. — recall Z-1446-2022

U.S. FDA — Device Enforcement · United States · 2020-09-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1446-2022
Date of alert
2020-09-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Aesculap Implant Systems LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04038653362325
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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