Reported Feb 5, 2014 · Terminated
Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k)…
Zimmer Dental Inc.
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: Zimmer Dental Inc · 1900 Aston Ave · Carlsbad, CA · 92008-7308
Is this the product you have?
Tapered Screw-Vent ImplantMTX4.7mm x 11.5mm4.5mm Platform. Catalog Number TSVWB11Lot 62470008. Class II510(k) K13227
- Lot codes and dates
Catalog Number TSVWB11Lot 62470008
- Amount recalled
- 307
Where it was sold
- Nationwide
Why it was recalled
Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog TSVWB11, Lot 62470008, because some of the packages of this lot may have the Cap Label state ¿3.7 x 10mm instead of ¿4.7 x 11.5mm.
This product could cause temporary or reversible health problems — stop using it.
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