ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Im...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0790-2020.
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0790-2020.
Recall ongoing. Follow firm instructions.
✅ 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 Implant Direct Sybron Manufacturing, Llc 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-0790-2020.
Implant Direct Sybron Manufacturing, 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 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.
Implant Direct Sybron Manufacturing, Llc Recall FAQ
Implant Direct Sybron Manufacturing, Llc is the subject of a medical implants safety report: ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Im.... The notice was published on November 28, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 274 units are potentially affected.