FDAClass IIJune 9, 2021

InterV recall

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)…

Why was InterV recalled?

Products distributed as sterile may not have been adequately sterilized

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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)…
Recalling firm
Zavation
Quantity
503 units
Distribution
US nationwide distribution.
Recall date
June 9, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls