medical Class II Updated 2021-06-09

Zavation recalls InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK

Recalled Product

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.

Hazard / Issue

Products distributed as sterile may not have been adequately sterilized

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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

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