Class II — Keystone Dental Inc
| Recalling firm | Keystone Dental Inc. |
|---|---|
| Registered facility | Keystone Dental Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment, |
| Product | Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. |
| Quantity | 35 units |
| Distribution | Nationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI. |
| Initiated | 2011-07-05 |
| Classified | 2013-03-08 |
| Terminated | 2013-03-11 |
| Recall number | Z-0923-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Keystone Dental Inc (Z-0923-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64477/
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