FDA Device recall Z-0961-2017
GoDirect Screw-Retaining Top Part Numbers: 4500-61
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of GoDirect Screw-Retaining Top Part Numbers: 4500-61 by Implant Direct Sybron Manufacturing, citing consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0961-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-28 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | WA |
Product
GoDirect Screw-Retaining Top Part Numbers: 4500-61
Reason
Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.
Identifiers
| code_info | Lot #75808 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0961-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.