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U.S. Department of Health and Human Services

Class 2 Device Recall Harvest, Illy, Jamblu, OsteoJ, PenBone, Pickup, Pressto

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  Class 2 Device Recall Harvest, Illy, Jamblu, OsteoJ, PenBone, Pickup, Pressto see related information
Date Initiated by Firm August 05, 2021
Create Date September 20, 2021
Recall Status1 Open3, Classified
Recall Number Z-2489-2021
Recall Event ID 88430
Product Classification Needle, biopsy, cardiovascular - Product Code DWO
Product Bone Marrow Transplantation biopsy needle
Code Information Model PI1535/100, Lot Numbers: 3620D Model PIL1410/75, Lot Numbers: 1617A Model PIL1435/100, Lot Numbers: 1617A Model PIL1510/75, Lot Numbers: 3620D, 3620E Model PIL1535/100, Lot Numbers: 5216C, 3620D Model PIL1610/75, Lot Numbers: 3620D, 3620E, 4120 Model PIL1635/100, Lot Numbers: 5216C Model PIL1835/100, Lot Numbers: 5216C Model PIP1410/50, Lot Numbers: 1617A Model PIP1430/70, Lot Numbers: 1617A Model PIP1510/50, Lot Numbers: 1217B, 1618A Model PIP1530/70, Lot Numbers: 1617A Model PIP1630/70, Lot Numbers: 1617A Model PIP1810/50, Lot Numbers: 0818, 1618A Model PIP1830/70, Lot Numbers: 1617A Model PJ0810, Lot Numbers: 3620D Model PJ1110, Lot Numbers: 3620D, 4920B Model PJ1306, Lot Numbers: 3620D Model PJE1110, Lot Numbers: 5216, 5216C, 1417A, 3517C, 4617, 0818, 1418, 2518A, 4018, 4318D, 5018, 1119B, 1119C, 1119A, 3620D Model PJK21110, Lot Numbers: 3616C, 3620D Model PJK21115, Lot Numbers: 3416C Model PJK21310, Lot Numbers: 3416C, 3620D Model PJT0810, Lot Numbers: 4220B, 4320D, 4320D Model PJT0815, Lot Numbers: 4220D, 4320E Model PJT1110, Lot Numbers: 1417A, 3620D, 3620D, 3620D, 4220B, 4220B, 4220B, 4220A, 4320F, 4320D Model PJT1115, Lot Numbers: 3620D, 4220B, 4320D Model PJT1306, Lot Numbers: 1417A, 3517C, 3620D, 3620E, 4220B, 4320D Model PJT1310, Lot Numbers: 3620D, 4220B, 4420A, 4320D Model PS0810, Lot Numbers: 2518A, 1119A Model PS1110, Lot Numbers: 4316, 4316A, 4316B, 4316B, 2618, 4018, 3620D Model PS1115, Lot Numbers: 3620D Model PS1306, Lot Numbers: 3620D Model PS1310, Lot Numbers: 3916, 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 21,518 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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