SwishPlus Implant 5 — Class II medical device recall Z-1126-2020
Terminated recall by Implant Direct Sybron Manufacturing LLC, reported 2020-02-19. Due to a complaint received and internal investigation it was determined that implant vials were distributed w
| Recall number | Z-1126-2020 |
|---|---|
| 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 | 2019-01-09 |
| Classified | 2020-02-10 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2021-04-27 |
| Countries outside the US | ES, IS, SE |
| Quantity | 11 units |
| Reason classes | labeling |
| Lot numbers | 109038 |
| Model numbers | 925708 |
Product
SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Reason for recall
Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
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-1126-2020. 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.