Implant Direct Recalls InterActive Implant Open-Tray Transfers Due to Sizing Error
Implant Direct is recalling 48 units of InterActive Implant Open-Tray Transfers because the wrong size was packaged, which may lead to oversized crown fabrication.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a manufacturing/packaging error that may lead to a functional issue (oversized crown) rather than a direct, immediate health injury or death.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 48 units of the InterActive Implant Open-Tray Transfer Narrow (Part Number 6534-08N, Lot #71664). The recall was initiated because the incorrect sized product, the InterActive Implant Open-Tray Transfer Wide (6534-08W), was packaged instead of the intended narrow version.
The discrepancy in product size may cause issues with the dental impression, potentially leading to the fabrication of an oversized crown. The affected units were distributed worldwide, including in the United States (OR, NE, VA, FL, MO, WA, TX) and in the countries of CZ, GB, NL, MF, DK, IT, IE, and DE.
Dental professionals and laboratories should stop using the affected units and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- 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…
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Affected units
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #71664
Distribution
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