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U.S. Department of Health and Human Services

Class 2 Device Recall Soft Tissue Biopsy

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  Class 2 Device Recall Soft Tissue Biopsy see related information
Date Initiated by Firm August 05, 2021
Create Date September 20, 2021
Recall Status1 Open3, Classified
Recall Number Z-2493-2021
Recall Event ID 88430
Product Classification Device, percutaneous, biopsy - Product Code MJG
Product General Manual surgical instrument
Code Information Model MGC1413, Lot Numbers: 0817A Model MGC1825, Lot Numbers: 0817A Model MGP1410, Lot Numbers: 5216C Model MGP1412, Lot Numbers: 5216C Model MGP1612, Lot Numbers: 5216C Model MGP1820, Lot Numbers: 5216C Model MGP1825, Lot Numbers: 0817A Model PC1610, Lot Numbers: 3620D Model PC1810, Lot Numbers: 3620D Model PC1815, Lot Numbers: 1217B Model PM14075, Lot Numbers: 5216C Model PM1410, Lot Numbers: 3620D Model PM14114, Lot Numbers: 5216C Model PM1415, Lot Numbers: 5216C Model PM16075, Lot Numbers: 5216C Model PM1610, Lot Numbers: 3620D Model PM16114, Lot Numbers: 5216C Model PM1615, Lot Numbers: 5216C Model PM18075, Lot Numbers: 5216C Model PM18114, Lot Numbers: 5216C Model PM1815, Lot Numbers: 5216C Model VE1410, Lot Numbers: 3620D Model VES1825, Lot Numbers: 1417A
Recalling Firm/
Manufacturer		 M.D.L. S.r.l.
Via Tavani N. 1/A
Delebio Italy
For Additional Information Contact Simone DellOca
390 342 682130
Manufacturer Reason
for Recall		 Sterility assurance may be compromised.
FDA Determined
Cause 2		 Other
Action The firm disseminated an URGENT: MEDICAL DEVICE RECALL notice on 08/05/2021 by email. The notice explained the issue and requested the return of any unused products. Distributors were instructed to notify their customers.
Quantity in Commerce 4120 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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