GoDirect Screw-Retaining Top Part Numbers: 4500-61 — Class II medical device recall Z-0961-2017
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2017-01-18. Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Re
| Recall number | Z-0961-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Westlake Village, CA, United States |
| Recall initiated | 2016-11-28 |
| Classified | 2017-01-09 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-02-16 |
| Countries outside the US | NL |
| Quantity | 14 |
| Reason classes | labeling |
| Lot numbers | 75808 |
| Model numbers | 4500-61 |
Product
GoDirect Screw-Retaining Top Part Numbers: 4500-61
Reason for recall
Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
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-0961-2017. 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.