Keystone Dental PrimaConnex Straight Implant Recall Due to Cover Screw Mismatch
Keystone Dental Inc. is recalling 55 units of PrimaConnex Straight Implants because small diameter cover screws were packaged with regular diameter implants.
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 the hazard involves a component mismatch that could lead to improper fit or function, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Keystone Dental Inc. is recalling 55 units of PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm (Product code: 15613K, Lot # 27714). The recall is due to a packaging error where small diameter (SD) cover screws were included with regular diameter (RD) implants, resulting in a mismatch between the screw and the implant diameter.
The affected implants are intended for use in partially or fully edentulous mandibles and maxillae to support single or multiple-unit restorations. The distribution was worldwide, including nationwide distribution in the United States to California, Colorado, Illinois, Massachusetts, Minnesota, North Dakota, New York, Nevada, Pennsylvania, and Virginia, as well as distribution to Italy.
Consumers and healthcare providers should stop using the affected implants and contact Keystone Dental Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, scre
- Manufacturer
- Keystone Dental Inc
- Category
- Medical Device — Dental Implants
- Affected units
- 55
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 # 27714
Distribution
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