Skip to main content
High RiskFDAfda-Z-2074-2015OTHER

Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was a...

Units Affected
149
Recall Date
June 22, 2015
Issuing Agency
Hazard
Other

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2074-2015.

One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2074-2015.

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-2074-2015.

Nobel Biocare Usa Llc

FDA

About the U.S. Food and Drug Administration

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

Visit FDA.gov →

📣 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.

How to report to FDAFile a report at FDA

Nobel Biocare Usa Llc Recall FAQ

Nobel Biocare Usa Llc is the subject of a medical implants safety report: Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was a.... The notice was published on June 22, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 149 units are potentially affected.