Reported Jun 9, 2021 · Terminated
ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. 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 Numbersa) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic / spinal procedures
- Lot codes and dates
- a) VCF-1015-2
- Lot Numbers
13814ZV10950ZV11694ZV10953ZV10779ZV10588ZV13664ZV13469ZV13519ZV10825ZV13885ZV12989ZV10933ZV13758ZV14107ZV14206ZV14680ZV14022ZV11603ZV10505ZV b) VCF-1015-2A
- Lot Numbers
10515ZV14197ZV14114ZV14113ZV14024ZV14023ZV13641ZV13471ZV13325ZV
- Amount recalled
- 195 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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