FDA recall Z-2831-2018

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-06-13

Report date

2018-08-22

Termination date

2018-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bristol, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2831-2018