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High RiskFDAfda-Z-1415-2015OTHER

Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to...

Units Affected
17
Recall Date
March 9, 2015
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1415-2015.

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1415-2015.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Nobel Biocare Usa Llc or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1415-2015.

Nobel Biocare Usa Llc

FDA

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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.

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📣 Report a food, supplement, or cosmetic problem to the FDA

If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.

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Nobel Biocare Usa Llc Recall FAQ

Nobel Biocare Usa Llc is the subject of a medical implants safety report: Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to.... The notice was published on March 9, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 17 units are potentially affected.