Implant Direct recalls a specific precision IO scan adapter (part #6530-09PT) due to a loose component 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 (part #653:09PT) because a loose part could fall into a patient's mouth during procedures, leading to aspiration or ingestion. This recall affects medical devices used in certain surgical procedures.
The adapter has a loose component 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 surgical procedure.
Medical professionals using the recalled adapter during procedures are most at risk. Patients undergoing surgery with this device could face aspiration or ingestion of the loose part.
Check for the part number 6530-09PT on the adapter label. The adapter is for 3.0mm platform, non-sterile, and requires a prescription (Rx). Lot numbers 104151, 106478, 114914, and 124072 are affected.
Look for the part number 6530-09PT on the adapter label to confirm if it's recalled.
The recall indicates a potential hazard, so it's not safe to use the recalled model without addressing the issue.
The official recall record does not specify a remedy, so contact the manufacturer for guidance.
Check for the part number 6530-09PT on the label, and the lot numbers 104151, 106478, 114914, or 124072.
We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.
Subject: Recall Z-0791-2020 — Implant Direct Implant Direct Hello, I own a Implant Direct that is covered by recall Z-0791-2020 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.
