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Class 2 Device Recall Scar markers |
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Date Initiated by Firm |
June 13, 2018 |
Create Date |
August 16, 2018 |
Recall Status1 |
Terminated 3 on November 13, 2018 |
Recall Number |
Z-2831-2018 |
Recall Event ID |
80558 |
Product Classification |
System, x-ray, film marking, radiographic - Product Code JAC
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Product |
S-SPOT REF 777, 777S
Adhere to skin for marking and identifying moles in mammography. |
Code Information |
REF 777 - Lot Numbers: 02281802 05301801 04041801 04211801 03301801 05101802 05241801 02191801 03151801 03281801 04281801 02131802 REF 777S - Lot Numbers |
Recalling Firm/ Manufacturer |
Beekley Corporation 1 Prestige Ln Bristol CT 06010-7468
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For Additional Information Contact |
860-583-4700
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Manufacturer Reason for Recall |
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
On June 14, 2018, Beekley Medical issued an "URGENT MEDICAL DEVICE RECALL" notice dated June 13, 2018 to customers. The notice described the products, problem and actions to be taken. Customers are advised to do the following:
- Inspect stock and quarantine affected product
- complete and return the acknowledgement response form via fax to: 1-800-735-1234 or mail.
- contact firm if inventory of affected product remains with customers at 1-800-233-5539 between 8:00am - 5:30pm EDT.
If you have any issues occurred or for further question, contact Quality Assurance & Regulatory Manager at 1-800-233-5539x434. |
Quantity in Commerce |
3,384,024 pieces in total. |
Distribution |
Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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