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Recall Observatory FDA recall evidence

Device product

Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern

Z-2109-2012

July 09, 2012

Class II

Product summary

Firm
Beekley Corporation
Event
Event 62526
Status
Terminated
Classification
Class II
Quantity
36,518 units
Official record key
device-enforcement:Z-2109-2012

Official wording

Reason: Digital Skin Mammography Marker separating from the backing of the spot material

Code information: Lot Numbers: A020, A021, A022, A023, A024, AO25, A026

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Digital Skin Mammography Marker separating from the backing of the spot material