6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number:… — Class II medical device recall Z-2046-2016
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2016-06-29, distributed nationwide. The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of th
| Recall number | Z-2046-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Westlake Village, CA, United States |
| Recall initiated | 2016-05-19 |
| Classified | 2016-06-23 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2016-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 48 |
| Lot numbers | 71664 |
| Model numbers | 6534-08N |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2046-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.