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Recall Observatory FDA recall evidence

Device product

S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.

Z-2831-2018

June 13, 2018

Class II

Product summary

Firm
Beekley Corporation
Event
Event 80558
Status
Terminated
Classification
Class II
Quantity
3,384,024 pieces in total.
Official record key
device-enforcement:Z-2831-2018

Official wording

Reason: There is a potential for imaging artifact to mimic calcifications on patient's mammograms

Code information: REF 777 - Lot Numbers: 02281802 05301801 04041801 04211801 03301801 05101802 05241801 02191801 03151801 03281801 04281801 02131802 REF 777S - Lot Numbers

Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for imaging artifact to mimic calcifications on patient's mammograms