Home / Recalls / Zavation / Z-1756-2021

Z-1756-2021 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
200 units

Product Description

OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. 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) INTV-OSFL, Lot Numbers: 11395ZV, 11285ZV, 11574ZV, 11471ZV b) INTV-OSFL-LV, Lot Numbers: 12386ZV

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  • Z-1763-2021 Class II — ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spin (March 25, 2021)
  • Z-1719-2021 Class II — 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orth (March 25, 2021)
  • Z-1761-2021 Class II — ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedi (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)
  • Z-1726-2021 Class II — ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For u (March 25, 2021)
  • Z-1753-2021 Class II — InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. Fo (March 25, 2021)
  • Z-1709-2021 Class II — ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For (March 25, 2021)
  • Z-1751-2021 Class II — InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) (March 25, 2021)
  • Z-1729-2021 Class II — ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK- (March 25, 2021)
  • Z-1731-2021 Class II — 10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures. (March 25, 2021)