Home / Recalls / Zavation / Z-1762-2021

Z-1762-2021 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
195 units

Product Description

ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. 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

a) VCF-1015-2, Lot Numbers: 13814ZV, 10950ZV, 11694ZV, 10953ZV, 10779ZV, 10588ZV, 13664ZV, 13469ZV, 13519ZV, 10825ZV, 13885ZV, 12989ZV, 10933ZV, 13758ZV, 14107ZV, 14206ZV, 14680ZV, 14022ZV, 11603ZV, 10505ZV b) VCF-1015-2A, Lot Numbers: 10515ZV, 14197ZV, 14114ZV, 14113ZV, 14024ZV, 14023ZV, 13641ZV, 13471ZV, 13325ZV

Other recalls by Zavation

  • Z-1741-2021 Class II — 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal proc (March 25, 2021)
  • Z-1732-2021 Class II — ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal (March 25, 2021)
  • Z-1704-2021 Class II — ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in O (March 25, 2021)
  • Z-1758-2021 Class II — ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic (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-1708-2021 Class II — ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK (March 25, 2021)
  • Z-1739-2021 Class II — 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures. (March 25, 2021)
  • Z-1755-2021 Class II — InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK (March 25, 2021)
  • Z-1726-2021 Class II — ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For u (March 25, 2021)
  • Z-1728-2021 Class II — ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use i (March 25, 2021)