Class II — Implant Direct Sybron Manufacturing, LLC
| Recalling firm | Implant Direct |
|---|---|
| Registered facility | IMPLANT DIRECT SYBRON MANUFACTURING LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component. |
| Product | Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component. |
| Quantity | 50 units |
| Distribution | Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT. |
| Initiated | 2017-07-21 |
| Classified | 2017-10-03 |
| Terminated | 2021-04-01 |
| Recall number | Z-0007-2018 |
| 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 — Implant Direct Sybron Manufacturing, LLC (Z-0007-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77788/
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