FDA Recall
Terminated
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
Recall: Z-1633-2021
·
Initiated March 22, 2021
Recall
- Recall Number
- Z-1633-2021
- 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 RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
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
10 units