CLASS II Device recall · Reported 15 Jan 2020 · FDA Enforcement Report
ImplantDirect InterActive Precision IO Scan Adapter recalled
Implant Direct Sybron Manufacturing is recalling ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform, distributed in 26 states. The recall was initiated on 28 Nov 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0791-2020
- FDA event ID
- 84067
- Recalling firm
- Implant Direct Sybron Manufacturing, Thousand Oaks, CA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 28 Nov 2018
- FDA classified
- 8 Jan 2020
- Reported
- 15 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 28 Nov 2018 | Recall initiated by company | |
| 8 Jan 2020 | Classified by FDA | +406 days |
| 15 Jan 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
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.
AlabamaArizonaCaliforniaFloridaGeorgiaKansasMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNebraskaNew JerseyNevadaNew YorkOhioOklahomaOregon
Questions about this recall
Is ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform recalled?
Yes. Implant Direct Sybron Manufacturing recalled ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform on 28 Nov 2018. The recall is Class II and its status is Completed. Recall number Z-0791-2020.
Why was it 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.
Which lots are affected?
Lot numbers 104151, 106478, 114914, and 124072.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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