Zavation recalls InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use…

Recall date

March 25, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1755-2021

FDA classification

Class II

Brand / firm

Zavation

Sold / distributed

US nationwide distribution.

Why it was recalled

Products distributed as sterile may not have been adequately sterilized

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures.