Implant Direct Recalls Swish Duo-Grip Healing Collars Due to Wrong Component
Implant Direct is recalling 50 units of Swish Duo-Grip Healing Collars because the packages contained the wrong component size.
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 minor labeling/packaging error (wrong component size) without reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or minor errors.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 50 units of the Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm. The product is a sterile, prescription-only dental implant component.
The recall was initiated because the package for part number 9048-13H (4.8mm) contained a 9037-13H (3.7 mm) component. This is a labeling and packaging error where the wrong size component was included in the package.
The affected product is identified by Product Code 9048-13H and Lot No. 81080. Distribution was nationwide, including California, Florida, New Jersey, New York, Pennsylvania, Texas, and Utah. Healthcare providers and patients should check their inventory for this specific lot and product code and stop using the affected units.
The recalled product
- Product
- Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Affected units
- 50
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)
- Product Code 9048-13H
- Lot No. 81080
Distribution
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