Reported Jun 9, 2021 · Terminated
ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
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?
- ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.
- Lot codes and dates
- Lot Numbers
13378ZV11141ZV10815ZV13971ZV13921ZV13577ZV13133ZV13033ZV11793ZV11695ZV12132ZV14105ZV12280ZV14389ZV13884ZV11956ZV11470ZV11342ZV10902ZV10516ZV14358ZV12266ZV10866ZV10651ZV14207ZV14021ZV11231ZV11465ZV12025ZV11537ZV11415ZV10998ZV11072ZV13883ZV
- Lot Numbers
- Amount recalled
- 516 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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