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

HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant. — recall Z-1259-2020

U.S. FDA — Device Enforcement · United States · 2019-03-18 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1259-2020
Date of alert
2019-03-18
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Advanced Bionics, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07630016832185
Reported risk: Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
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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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.