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 #6534-09PT, 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-0790-2020
- 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
- Other Reasons
- 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.
Product as listed by the FDA
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.
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
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 104479 and 104963.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 84067This product is part of a recall event; the main page for the event is ImplantDirect InterActive Precision IO Scan Adapter recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ImplantDirect InterActive Precision IO Scan Adapter recalled | Implant Direct Sybron Manufacturing | Other | 26 states |
More recalls from Implant Direct Sybron Manufacturing
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|---|---|---|---|---|---|
| Device | CLASS II | The Drill Stop Kit recalled by Implant Direct Sybron | Implant Direct Sybron Manufacturing | Other | Nationwide |
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