Genesis Straight Esthetic 5 — Class II medical device recall Z-0924-2013
Terminated recall by Keystone Dental Inc, reported 2013-03-20, distributed nationwide. Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm
| Recall number | Z-0924-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Dental Inc, Burlington, MA, United States |
| Recall initiated | 2011-07-05 |
| Classified | 2013-03-08 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 22 units |
| Reason classes | labeling |
| Lot numbers | 2385 |
| Model numbers | G71205 |
| Expiration dates | 2013-09 |
Product
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Reason for recall
Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0924-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.