Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGESsee related information
Date Initiated by FirmMarch 22, 2021
Date PostedMay 19, 2021
Recall Status1 Terminated 3 on February 17, 2026
Recall NumberZ-1646-2021
Recall Event ID 87696
Product Classification Bone cement - Product Code LOD
Product10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
Code Information LOT: 2002439, 20051290, 20061420, 20081943    
Recalling Firm/
Manufacturer		 BIOPSYBELL S.R.L.
Via Aldo Manuzio N. 24
Via A.Manuzio n.24
Mirandola Italy
Manufacturer Reason
for Recall		Products labeled as sterile were distributed, but may not have been sterilized.
FDA Determined
Cause 2		Vendor change control
ActionThe firm notified two consignees with the preliminary information by email on 03/22/2021 and followed with the official notice with the complete information on 04/08/2021 to all consignees. The letter requested that the consignee cease using the affected product and contact Biopsybell or a Biopsybell representative for product return/disposal and related replacement. Distributors were directed to identify those who received the product and notify them.
Quantity in Commerce305 units
DistributionUS Nationwide distribution in the states MS and KY.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-