Keystone Dental Recalls PrimaConnex Straight Implants Due to Mislabeling
Keystone Dental Inc. is recalling 59 PrimaConnex Straight Implants because they were incorrectly labeled as Tapered Implants.
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 involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Keystone Dental Inc. is recalling 59 units of PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm (Catalog Number 15636K, Lot Number 30214). The recall was initiated because the Straight PrimaConnex Implants were contained in packaging labeled as Tapered PrimaConnex Implants.
The affected products were distributed to facilities in California, Illinois, Indiana, Florida, Massachusetts, Minnesota, New Jersey, Nevada, and Pennsylvania. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Dental professionals and patients should check their inventory for the specific catalog and lot numbers listed above. If the product is found, it should be removed from use and returned to Keystone Dental Inc. according to the firm's instructions.
The recalled product
- Product
- Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
- Manufacturer
- Keystone Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 59
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 Number: 30214
Distribution
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