Recall Z-1636-2021
Biopsybell S.R.L. · initiated March 22, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
Codes / lots: BATCH:2003721
Reason for recall
Products labeled as sterile were distributed, but may not have been sterilized.
FDA-determined cause: Vendor change control
Action taken
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.
Details
- Recall number
- Z-1636-2021
- Initiated
- March 22, 2021
- Posted by FDA
- May 19, 2021
- Terminated
- February 17, 2026
- Product code
- LOD – Bone Cement
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the states MS and KY.
- Recalling firm
- Biopsybell S.R.L., Mirandola
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1631-2021 Class II | BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing systemProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1632-2021 Class II | RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-USProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1633-2021 Class II | BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES…Products labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1634-2021 Class II | BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111Products labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1635-2021 Class II | CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051Products labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1637-2021 Class II | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBDProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1638-2021 Class II | 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDCProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1639-2021 Class II | 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAKProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1640-2021 Class II | 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCBProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1641-2021 Class II | 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDKProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1642-2021 Class II | CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMSProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1643-2021 Class II | 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCDProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1644-2021 Class II | 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAKProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1645-2021 Class II | 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCBProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1646-2021 Class II | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDKProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1647-2021 Class II | 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15Products labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1648-2021 Class II | 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CCProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |
| Z-1649-2021 Class II | 10 GAUGE DRILL, CODE INTVM-DRLProducts labeled as sterile were distributed, but may not have been sterilized. | 03/22/2021Terminated |