Keystone Dental Recalls Genesis Surgical Cassettes Due to Burr Wobble
Keystone Dental Inc is recalling 19 Genesis Surgical Cassettes because extra-large grommets cause dental burrs to wobble.
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 defect involves a mechanical issue (wobbling burrs) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Keystone Dental Inc is recalling 19 units of Genesis Surgical Cassette Tapered Implants. These products are intended for placement following natural tooth loss or for immediate placement into an extraction socket.
The recall was initiated because the surgical cassettes contained extra-large white grommets. This defect causes the 3.8 mm and 6.5 mm dental burrs to wobble within the grommets. The affected units are identified by lot numbers 38177, 38330, and 38421.
The products were distributed nationwide in the United States and internationally to Turkey. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
- Manufacturer
- Keystone Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 19
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 #s 38177 38330 38421
Distribution
Distributed nationwide across the United States.
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