Keystone Dental Recalls Stage-1 Tissue Punches Due to Damaged Cutting Edges
Keystone Dental Inc is recalling 101 Stage-1 Tissue Punches because the cutting edges may have small dents and nicks.
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 potential damage to the cutting edge (dents and nicks) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Keystone Dental Inc is recalling 101 units of the Stage-1 Tissue Punch, Disposable, 4.5mm (catalog number ISS141K). The recall was initiated because the cutting edge of the tissue punches may be potentially damaged with small dents and nicks.
The affected products were distributed worldwide to the United States (specifically the state of California), Canada, and Germany. The recalled units include lot numbers 33434 (expiration 2022-04), 33945 (expiration 2022-05), 34294 (expiration 2022-06), and 34987 (expiration 2022-07).
Dental professionals and patients who have used or possess these specific lot numbers should contact Keystone Dental Inc for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
- Manufacturer
- Keystone Dental Inc
- Hazard
- Affected units
- 101
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 (8)
- Lot numbers: 33434
- expiration date: 2022-04
- 33945
- expiration date: 2022-05
- 34294
- expiration date: 2022-06
- and 34987
- expiration date: 2022-07.
Distribution
Distributed in 1 state:
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