RecallRadar

FDA Device recall Z-1753-2021

InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures

On 2021-06-09 the FDA classified a Class II recall of InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures by Zavation, citing products distributed as sterile may not have been adequately sterilized.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1753-2021
ClassificationClass II
Statusterminated
Initiated2021-03-25
Published2021-06-09
Last updated2026-09-13 11:56 UTC
CompanyZavation
DistributionUS

Product

InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.

Reason

Products distributed as sterile may not have been adequately sterilized

Identifiers

code_infoa) INTVMC-15-FLDSK, Lot Numbers: 10659ZV b) INTVMC-20-FLDSK, Lot Numbers: 10312ZV, 11698ZV, 10276ZV, 10205ZV, 10031ZV

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1753-2021%22

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