medical Class II Updated 2020-01-15

Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect InterActive Precision IO Scan Adapter, Part #6

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, AZ, CA, FL, GA, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA
Lot/Code Info: Lot numbers 104151, 106478, 114914, and 124072.
View official government recall

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