FDA Recall
Terminated
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Recall: Z-1631-2021
·
Initiated March 22, 2021
Recall
- Recall Number
- Z-1631-2021
- Event Number
- 87696
- Firm
- BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy
- FEI Number
- 3003272754
- Product Code
- LOD
- Status
- Terminated
- Root Cause
- Vendor change control
- Initiated
- March 22, 2021
- Posted
- May 19, 2021
- Terminated
- February 17, 2026
Description
BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system
Reason
Products labeled as sterile were distributed, but may not have been sterilized.
Action
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.
Distribution
US Nationwide distribution in the states MS and KY.
Quantity
5 units