Reported Apr 4, 2018 · Terminated
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
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 MTX, Dental Implant, sterile. Model TSV4B10.
- Lot codes and dates
- Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
- Amount recalled
- 995 distribution events total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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