FDA Device recall Z-2070-2017
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
- FDA Device
- Class II
- terminated
- Published 2017-05-17
On 2017-05-17 the FDA classified a Class II recall of Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048 by Mentor Texas, citing missing Dome Pack accessory.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2070-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-27 |
| Published | 2017-05-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Mentor Texas |
| Distribution | CA, CT, IL, IN, MI, NC, NY, OH, OK |
Product
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Reason
Missing Dome Pack accessory.
Identifiers
| code_info | Lot Number: 7377332 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2026-04-08 · Mentor Texas - CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
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FDA Device · Class II · 2026-04-08 · Mentor Texas - Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Prof…
FDA Device · Class II · 2026-04-08 · Mentor Texas
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2070-2017%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.