Reported Jun 9, 2021 · Terminated
InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use…
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 11G Kyphoplasty Kit
- REF Numbersa) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. For use in Orthopedic / spinal procedures
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 Lot Numbers: 10816ZV, 13708ZV, 13845ZV, 13522ZV, 12133ZV c) INTVMN-15-DSKC 2 Lot Numbers: 11843ZV, 11412ZV, 11160ZV, 11017ZV d) INTVMN-20-DSK 3 Lot Numbers: 14266ZV, 14238ZV, 12524ZV, 11756ZV, 11083ZV - Amount recalled
- 119 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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