NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2828-2020.
Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2828-2020.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Nobel Biocare Services Ag or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- 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-2828-2020.
NOBEL BIOCARE SERVICES AG
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.
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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.
Nobel Biocare Services Ag Recall FAQ
Nobel Biocare Services Ag is the subject of a medical implants safety report: NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower .... The notice was published on July 20, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 188 units are potentially affected.