Implant Direct Legacy Implant Closed-Tray Transfer Mislabeled Cap Recall
Implant Direct is recalling 217 units of Legacy Implant Closed-Tray Transfer components due to potential cap mislabeling. The correct part number is on the main vial label.
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, but the hazard is limited to a labeling error on the cap where the correct information is available on the main vial, fitting the criteria for minor labeling errors.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 217 units of the Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. This dental implant component is used temporarily during impressions for prosthetic procedures. The recall is due to a labeling error where the cap may be mislabeled with an incorrect part number, although the correct part number is present on the main vial label.
The affected product is identified by Part number 8735-05 and Lot number 90212. The units were distributed worldwide, including the United States, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.
Healthcare professionals and consumers should check their inventory for this specific part and lot number. If the product is found, it should be removed from use and returned to the manufacturer or distributor for further instructions.
The recalled product
- Product
- Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Hazard
- Affected units
- 217
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 (2)
- Part number 8735-05
- Lot number 90212
Distribution
Distributed nationwide across the United States.
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