Reported Jun 9, 2021 · Terminated

InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e)…

Zavation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zavation · 220 Lakeland Pkwy · Flowood, MS · 39232-9552

Is this the product you have?

  • InterV, 10G Kyphoplasty Kits
  • REF numbersa) 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
Lot codes and dates

8 of 8 products

Products covered by this recall
#Product as published
1INTVM-10-DSK, lot numbers:13724ZV, 13517ZV, 13384ZV, 11658ZV, 12985ZV, 12259ZV, 11692ZV
2INTVM-10-SBK, lot numbers:12400ZV, 10784ZV, 14384ZV, 12329ZV, 11928ZV
3INTVM-15-DSK, lot numbers:12885ZV, 12108ZV, 11294ZV, 13761ZV, 11071ZV, 13908ZV, 13846ZV, 12193ZV, 11848ZV, 11624ZV, 11463ZV, 11035ZV, 10941ZV, 13410ZV, 13010ZV, 12654ZV, 12308ZV
4INTVM-15-DSKC, lot numbers:11489ZV, 11140ZV, 10904ZV
5INTVM-15-SBK, lot numbers:11219ZV, 11611ZV, 11538ZV
6INTVM-15-SIKBC, lot numbers:11725ZV, 11221ZV, 10988ZV, 10901ZV
7INTVM-20-DSK, lot numbers:11483ZV, 11250ZV
8INTVM-20-SBK, lot numbers:10954ZV, 11697ZV, 11704ZV
Amount recalled
503 units

This recall covers 71 products

The agency filed one notice per product. You are reading one of them; the other 70 are below.

58 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Products distributed as sterile may not have been adequately sterilized

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 20, 2023 · Data as of Sep 19, 4:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.