SwishPlus Implant Intended for use in support for fixed bridgework — Class II medical device recall Z-1168-2018
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2018-03-28. The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the inco
| Recall number | Z-1168-2018 |
|---|---|
| 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 | 2018-01-19 |
| Classified | 2018-03-22 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2023-07-26 |
| Countries outside the US | AU, CA, JP |
| Quantity | 1,117 units |
| Lot numbers | 924108, 924112, 924116, 924806, 924810W, 924812W, 924814, 93563 |
| Model numbers | 924108, 924112, 924116, 924806, 924810W, 924812W, 924814, 93563 |
Product
SwishPlus Implant Intended for use in support for fixed bridgework.
Reason for recall
The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
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-1168-2018. 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.