Keystone Dental Recalls Mispackaged Plastic Abutment Sleeves
Keystone Dental Inc is recalling 55 units of plastic abutment sleeves that were packed as non-locking but are actually locking.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging error without reported injuries.
Plain-English summary
Keystone Dental Inc is recalling 55 units of STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit (Catalog Number: S2437-01-1K). The recall involves lots 35026, 35579, and 36133.
The recall was initiated because a locking plastic abutment sleeve was packed as a non-locking plastic abutment sleeve. These sleeves are used by dental technicians in dental laboratories to aid in the creation of the final restorative crown.
The affected products were distributed internationally to Germany only. The source text does not specify instructions for consumers or dental laboratories regarding the disposition of these units.
The recalled product
- Product
- STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
- Manufacturer
- Keystone Dental Inc
- Category
- Medical Device — Dental
- Hazard
- 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 (3)
- Lots: 35026
- 35579
- 36133
Distribution
Distribution scope not specified by the agency.
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