Home / Recalls / Zavation / Z-1751-2021

Z-1751-2021 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
503 units

Product Description

InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. 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) INTVM-10-DSK, lot numbers:13724ZV, 13517ZV, 13384ZV, 11658ZV, 12985ZV, 12259ZV, 11692ZV b) INTVM-10-SBK, lot numbers:12400ZV, 10784ZV, 14384ZV, 12329ZV, 11928ZV c) INTVM-15-DSK, lot numbers:12885ZV, 12108ZV, 11294ZV, 13761ZV, 11071ZV, 13908ZV, 13846ZV, 12193ZV, 11848ZV, 11624ZV, 11463ZV, 11035ZV, 10941ZV, 13410ZV, 13010ZV, 12654ZV, 12308ZV d) INTVM-15-DSKC, lot numbers:11489ZV, 11140ZV, 10904ZV e) INTVM-15-SBK, lot numbers:11219ZV, 11611ZV, 11538ZV f) INTVM-15-SIKBC, lot numbers:11725ZV, 11221ZV, 10988ZV, 10901ZV g) INTVM-20-DSK, lot numbers:11483ZV, 11250ZV h) INTVM-20-SBK, lot numbers:10954ZV, 11697ZV, 11704ZV

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)