Reported Jun 29, 2016 · Terminated
6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant…
Implant Direct Sybron Manufacturing, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Implant Direct Sybron Manufacturing, LLC · 3050 E Hillcrest Dr · Westlake Village, CA · 91362-3171
Is this the product you have?
- 6534-08N InterActive¿ Implant
- Open-Tray Transfer Narrow Part Number6534-08N
- Product UsageIntended 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
- Lot codes and dates
- Lot #71664
- Amount recalled
- 48
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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