Implant Direct recalls a precision IO scan adapter (part #6534-09PT) due to a loose part that could fall into a patient's mouth during procedures, causing aspiration or ingestion.
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.
Implant Direct is recalling a specific precision IO scan adapter used in medical procedures because a loose part could fall into a patient's mouth during surgery, leading to aspiration or ingestion. This recall affects devices sold with lot numbers 104479 and 104963.
The adapter has a loose part that can detach from the titanium base during use. If this part falls into a patient's mouth, it could cause aspiration (breathing in the part) or ingestion (swallowing the part) during a medical procedure.
Healthcare professionals using this device during medical procedures are most at risk. Patients undergoing procedures with this device could face aspiration or ingestion of the loose part.
Check for the part number 6534-09PT on the label. The device is sold with lot numbers 104479 or 104963 and is non-sterile, requiring a prescription (Rx).
Look for the part number 6534-09PT and lot numbers 104479 or 104963 on the device label.
The recall states the device has a loose part that could fall into a patient's mouth during procedures, so it is not safe to use as recalled.
The recall does not specify a remedy, so contact the manufacturer for guidance.
Check for the part number 6534-09PT and lot numbers 104479 or 104963 on the device label.
We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.
Subject: Recall Z-0790-2020 — Implant Direct Implant Direct Hello, I own a Implant Direct that is covered by recall Z-0790-2020 from Implant Direct. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
