Keystone Dental Recalls Mislabeled PrimaConnex Tapered Dental Implants
Keystone Dental Inc is recalling 120 units of PrimaConnex Tapered Implants because the included cover screw was a WD type instead of the labeled SD type.
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 source text explicitly states the issue is a mislabeling of the cover screw type without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Keystone Dental Inc is recalling 120 units of PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm (Catalog Number: l5613K). The recall is due to a labeling error where the cover screw included in the package was a WD cover screw, not the SD cover screw as labeled on the product.
The affected products are identified by Lot Number 12857. These implants are used in support for fixed bridgework. The distribution pattern includes worldwide distribution to the USA (including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY) and the countries of Republic of China, Germany, and France.
The source text does not specify specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it report any illnesses or injuries associated with the mislabeling.
The recalled product
- Product
- PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
- Manufacturer
- Keystone Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 120
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: 12857
Distribution
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