Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave pr...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1168-2014.
During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1168-2014.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1168-2014.
Biomet 3i, LLC
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 an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Biomet 3i, Llc Recall FAQ
Biomet 3i, Llc is the subject of a surgical devices safety report: Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave pr.... The notice was published on July 22, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 170 units are potentially affected.