Skip to content
Recall Observatory FDA recall evidence

Device product

Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

Z-2404-2026

April 29, 2026

Class II

Product summary

Firm
Boston Scientific Neuromodulation Corporation
Event
Event 98941
Status
Ongoing
Classification
Class II
Quantity
43 units
Official record key
device-enforcement:Z-2404-2026

Official wording

Reason: Sterile anchors my lack sterility assurance.

Code information: GTIN: 08714729905318/Lot # 35107836

Distribution pattern: US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterile anchors my lack sterility assurance.