ImplantDirect InterActive Precision IO Scan Adapter recall
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct…
Why was ImplantDirect InterActive Precision IO Scan Adapter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers 104479 and 104963.
- Product
- ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct…
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 274 devices
- Distribution
- Distribution was made to 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, and VA. There was no government/military distribution. Foreign distribution was made to Canada, Armenia, Australia, Denmark, France, Germany, Great Britain, Iceland, Italy, Lithuania, Netherlands, Poland, Spain, Sweden, and Switzerland.
- Recall date
- January 15, 2020
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)