BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
Brand
BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy
Lot Codes / Batch Numbers
BATCH:2003721
Products Sold
BATCH:2003721
BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy is recalling EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS due to Products labeled as sterile were distributed, but may not have been sterilized.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Products labeled as sterile were distributed, but may not have been sterilized.
Recommended Action
Per FDA guidance
The 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026