Reported Dec 27, 2017 · Terminated

Tapered Screw-Vent MTX Model TSVTB11

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 Model TSVTB11
Lot codes and dates
  • lot,#63519794
  • UDI(01)00889024019935 (17)211130 (10)63519794
Amount recalled
500 units

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Why it was recalled

Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 28, 2024 · Data as of Sep 19, 5:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.