FDANovember 28, 2018device
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Completed
Brands named
implant direct sybron manufacturingimplantimplant direct
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCKawasaki Motors USA Recalls Model Year 2026 Teryx4 H2 and Teryx5 H2 Recreational Off-Road Vehicles Due to Impact and Injury Hazards2026-06-11
- CPSCPressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Imported by Patoolio Direct2026-04-16
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- FDAHandy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd2026-02-18
- CPSCFortemotus Direct Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails2026-02-12
- CPSCWatkins Manufacturing Recalls Hydromassage Rotary Jets in Highlife Collection Spas Due to Entanglement and Drowning Hazards2026-02-12
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