CLASS II Device recall · Reported 29 Jun 2016 · FDA Enforcement Report
6534-08N InterActive¿ Implant Open-Tray Transfer Narrow recalled
Implant Direct Sybron Manufacturing is recalling 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow, distributed nationwide in the US. The recall was initiated on 19 May 2016 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-2046-2016
- FDA event ID
- 74208
- Recalling firm
- Implant Direct Sybron Manufacturing, Westlake Village, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2016
- FDA classified
- 23 Jun 2016
- Reported
- 29 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 19 May 2016 | Recall initiated by company | |
| 23 Jun 2016 | Classified by FDA | +35 days |
| 29 Jun 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression. This discrepancy may lead to the possibility of an oversized crown fabrication.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Transfers are to capture implant position in an elastomeric impression of the mandible or maxilla. Open Tray transfers stay within the Impression material prior to delivery to the laboratory technician.
Where it was distributed
Worldwide Distribution - U.S. Nationwide in the states of OR, NE, VA, FL, MO, WA, TX and the countries of CZ, GB, NL, MF, DK, IT, IE, DE
Nationwide DelawareFloridaMissouriNebraskaTexasVirginiaWashington
Questions about this recall
Is 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow recalled?
Yes. Implant Direct Sybron Manufacturing recalled 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow on 19 May 2016. The recall is Class II and its status is Terminated. Recall number Z-2046-2016.
Why was it recalled?
The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression. This discrepancy may lead to the possibility of an oversized crown fabrication.
Which lots are affected?
Lot #71664
Where was it sold?
Worldwide Distribution - U.S. Nationwide in the states of OR, NE, VA, FL, MO, WA, TX and the countries of CZ, GB, NL, MF, DK, IT, IE, DE
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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