Implant Direct Recalls GoDirect Screw-Retaining Top Due to Labeling Error
Implant Direct Sybron Manufacturing is recalling 14 units of GoDirect Screw-Retaining Top (Part No. 4500-61) because they were shipped with incorrect labels for a different product.
What this means for you
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 involves a labeling error. Per the rubric, minor labeling errors and voluntary precautionary recalls are classified as Moderate (Score 2).
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 14 units of the GoDirect Screw-Retaining Top, Part Number 4500-61. The recall is due to a labeling error where the product was shipped with the label for a different item, the 6060-62 Replant Overdenture Abutment.
The affected units are from Lot #75808. The product was distributed in the United States to Washington and internationally to the Netherlands.
Consumers and healthcare providers should stop using the affected product and contact the manufacturer for instructions on how to return the items.
The recalled product
- Product
- GoDirect Screw-Retaining Top Part Numbers: 4500-61
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 14
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 #75808
Distribution
Distribution scope not specified by the agency.
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