| Class 2 Device Recall Automark, Mark, Markslim, Repomark | |
Date Initiated by Firm | August 05, 2021 |
Create Date | September 20, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2491-2021 |
Recall Event ID |
88430 |
Product Classification |
Guide, needle, surgical - Product Code GDF
|
Product | Mammary Nodules Localization |
Code Information |
Model Number PN2010, Lots: 3620D
Model Number PN2012, Lots: 1317
Model Number PN2015, Lots: 3620D
Model Number PNA2005, Lots: 5216C
Model Number PNA2010, Lots: 3620D
Model Number PNA2015, Lots: 3620D
Model Number PNAX2005, Lots: 5216C
Model Number PNS2010, Lots: 3620D
Model Number PNS2015, Lots: 3620D
Model Number PNX2010, Lots: 0817A
Model Number PR2005, Lots: 5216C, 4920B
Model Number PR2007, Lots: 5216C
Model Number PR2010, Lots: 3620D
Model Number PR2015, Lots: 3620D
|
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 | 320 units |
Distribution | Nationwide |
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 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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