Implant Direct Sybron Manufacturing, LLC Recall: 6534-08N InterActive¿ Implant Open-Tray T
Implant Direct Sybron Manufacturing, LLC Recall: 6534-08N InterActive¿ Implant Open-Tray T is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Implant Direct Sybron Manufacturing, LLC; Product: 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Int
| Recalling firm | Implant Direct Sybron Manufacturing, LLC |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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 |
| Recall initiated | 20160519 |
| Recall number | Z-2046-2016 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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