Unrated Medical device recall · FDA · Published November 28, 2018

Implant Direct Precision IO Scan Adapter Recall: Loose Part Risk During Procedures

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0791-2020Medical device Implant Direct ›

Recall notice

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.

Take action

Contact the company

Recalling firmImplant Direct Sybron Manufacturing, LLC3050 E Hillcrest Dr · Thousand Oaks, CA 91362

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/69419-implant-direct-precision-io-scan-adapter-recall-loose-part-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69419-implant-direct-precision-io-scan-adapter-recall-loose-part-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0791-2020

Cite this page

“Implant Direct Precision IO Scan Adapter Recall: Loose Part Risk During Procedures.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69419-implant-direct-precision-io-scan-adapter-recall-loose-part-risk. Based on FDA recall #Z-0791-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0791-2020%22&limit=1).

Implant Direct Sybron Manufacturing LLC recalled ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, due to a loose peek part that could fall into a patient's mouth. The Food and Drug Administration announced the Class II recall on November 28, 2018.

How to tell if you have it

ImplantDirect InterActive Precision IO Scan Adapter
Part #6530-09PT
Platform: 3.0mm
Lot numbers 104151, 106478, 114914, and 124072

The hazard

The loose peek part on the titanium base could result in the device falling into a patient's mouth during a procedure. This poses a risk of aspiration or ingestion.

Context

GovInfoNow's records show Implant Direct Sybron Manufacturing LLC has had 20 other recalls since June 26, 2017. Recent brand recalls include the May 1, 2025 Sybron Drill Stop Kit Recall for incorrect components and the Sept. 23, 2021 Implant Direct Legacy 2 Dental Implant Recall for wrong size labeling. Other recent recalls of similar products include the May 25, 2026 Medtronic Bio-Medicus Adult Cannula Kit Recall and the Oct. 30, 2025 Olympus HX-400U-30 Ligating Device Recall.

How to tell if you have this one

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.

Brand
Implant Direct
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Completed
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 number	Product, codes & lots	Quantity
Z-0790-2020	ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.; Lot numbers 104479 and 104963.	274 devices
Z-0791-2020	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.; Lot numbers 104151, 106478, 114914, and 124072.	232 devices

Based on the official FDA remedy

What to do — step by step

Check Device Label
Look for the part number 6530-09PT on the adapter label to confirm if it's recalled.

Where it went and when

Where it was distributed

Distributed in 26 states, and outside the U.S.

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Florida, Georgia, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia.

Recall timeline

FDA published this recall 14 months after the firm started it.

Nov 28, 2018Firm started the recall
Jan 8, 2020FDA classified it Class II
Jan 15, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this device safe to use?

The recall indicates a potential hazard, so it's not safe to use the recalled model without addressing the issue.

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Link to this recall

<a href="https://govinfonow.com/recall/69419-implant-direct-precision-io-scan-adapter-recall-loose-part-risk">Implant Direct Precision IO Scan Adapter Recall: Loose Part Risk During Procedures (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0791-2020 (November 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0791-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.