Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline… — Class II medical device recall Z-2070-2017
Terminated recall by Mentor Texas, LP., reported 2017-05-17, distributed in CA, CT, IL, IN, MI, NC, NY, OH…. Missing Dome Pack accessory.
| Recall number | Z-2070-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mentor Texas, LP., Irving, TX, United States |
| Recall initiated | 2017-03-27 |
| Classified | 2017-05-11 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2017-06-13 |
| Distributed | CA, CT, IL, IN, MI, NC, NY, OH, OK |
| Quantity | 28 units |
| UPC / GTIN / UDI-DI | 00081317002048 |
| Lot numbers | 7377332 |
Product
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Reason for recall
Missing Dome Pack accessory.
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-2070-2017. 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.