Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2535-2016.
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2535-2016.
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 Straumann Manufacturing, Inc. 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-2535-2016.
Straumann Manufacturing, Inc.
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.
Straumann Manufacturing, Inc. Recall FAQ
Straumann Manufacturing, Inc. is the subject of a medical implants safety report: Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512. The notice was published on July 14, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 33 units are potentially affected.