Home / Recalls / BIOPSYBELL S.R.L. / Z-1631-2021

Z-1631-2021 Class II Terminated

Recalled by BIOPSYBELL S.R.L. — Mirandola, N/A

Recall Details

Product Type
Devices
Report Date
May 26, 2021
Initiation Date
March 22, 2021
Termination Date
February 17, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

Product Description

BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system

Reason for Recall

Products labeled as sterile were distributed, but may not have been sterilized.

Distribution Pattern

US Nationwide distribution in the states MS and KY.

Code Information

BATCH: 19123253

Other recalls by BIOPSYBELL S.R.L.

  • Z-1636-2021 Class II — EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGU (March 22, 2021)
  • Z-1639-2021 Class II — 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK (March 22, 2021)
  • Z-1632-2021 Class II — RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US (March 22, 2021)
  • Z-1645-2021 Class II — 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB (March 22, 2021)
  • Z-1634-2021 Class II — BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF O (March 22, 2021)
  • Z-1643-2021 Class II — 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD (March 22, 2021)
  • Z-1635-2021 Class II — CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051 (March 22, 2021)
  • Z-1633-2021 Class II — BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, (March 22, 2021)
  • Z-1648-2021 Class II — 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC (March 22, 2021)
  • Z-1638-2021 Class II — 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC (March 22, 2021)