Home / Recalls / Zavation / Z-1769-2021

Z-1769-2021 Class II Terminated

Recalled by Zavation — Flowood, MS

Recall Details

Product Type
Devices
Report Date
June 9, 2021
Initiation Date
March 25, 2021
Termination Date
March 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
140 units

Product Description

VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal procedures.

Reason for Recall

Products distributed as sterile may not have been adequately sterilized

Distribution Pattern

US nationwide distribution.

Code Information

Lot Numbers: 10085ZV, 10086ZV, 11205ZV, 11217ZV, 11554ZV, 11558ZV, 11559ZV

Other recalls by Zavation

  • Z-1770-2021 Class II — VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spina (March 25, 2021)
  • Z-1749-2021 Class II — 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in O (March 25, 2021)
  • Z-1736-2021 Class II — 11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. (March 25, 2021)
  • Z-1727-2021 Class II — 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal pro (March 25, 2021)
  • Z-1748-2021 Class II — 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures. (March 25, 2021)
  • Z-1763-2021 Class II — ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spin (March 25, 2021)
  • Z-1734-2021 Class II — 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. (March 25, 2021)
  • Z-1746-2021 Class II — 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures. (March 25, 2021)
  • Z-1700-2021 Class II — 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use (March 25, 2021)
  • Z-1737-2021 Class II — 11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures. (March 25, 2021)