Home / Recalls / BIOPSYBELL S.R.L. / Z-1639-2021

Z-1639-2021 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
330 units

Product Description

10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK

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

LOT: 2001201, 2003859, 20051288, 20061419

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-1631-2021 Class II — BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixi (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)