Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ImplantDirect InterActive Precision IO Scan Adapter Recalled by Implant Direct Sybron Manufacturing, LLC Due to The peek part was loose on the titanium...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Implant Direct Sybron Manufacturing, LLC directly.
Affected Products
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Quantity: 274 devices
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 26 states: AL, AZ, CA, FL, GA, KS, MD, MA, MI, MN, MO, MT, NE, NV, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA
About Implant Direct Sybron Manufacturing, LLC
Implant Direct Sybron Manufacturing, LLC has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report