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 1 INTVM-10-DSK, lot numbers:13724ZV, 13517ZV, 13384ZV, 11658ZV, 12985ZV, 12259ZV, 11692ZV 2 INTVM-10-SBK, lot numbers:12400ZV, 10784ZV, 14384ZV, 12329ZV, 11928ZV 3 INTVM-15-DSK, lot numbers:12885ZV, 12108ZV, 11294ZV, 13761ZV, 11071ZV, 13908ZV, 13846ZV, 12193ZV, 11848ZV, 11624ZV, 11463ZV, 11035ZV, 10941ZV, 13410ZV, 13010ZV, 12654ZV, 12308ZV 4 INTVM-15-DSKC, lot numbers:11489ZV, 11140ZV, 10904ZV 5 INTVM-15-SBK, lot numbers:11219ZV, 11611ZV, 11538ZV 6 INTVM-15-SIKBC, lot numbers:11725ZV, 11221ZV, 10988ZV, 10901ZV 7 INTVM-20-DSK, lot numbers:11483ZV, 11250ZV 8 INTVM-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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