Mentor Smooth Round SPECTRUM Post recallZ-2070-2017 · Mentor Texas, LP. · initiated Mar 27, 2017
Class II Terminated All recalls posted in May 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mentor Texas, LP. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Missing Dome Pack accessory.
FDA root cause category: Other
What the company is doing
Mentor sent an Recall Notification letter dated March 27, 2017 was sent to consignees (hospitals/doctors) . Actions Requested If you have already implanted a device from this lot, there is no risk to patient health and you do not need to take any action. Immediately identify all unused units and return them to Mentor per the normal return process.Forward this notice to anyone in your facility that needs to be informed. If you have sent these units to another facility, forward this notice to that facility. Maintain awareness of this notice until all units from lot number 7377332 in your inventory have been returned. We apologize for any inconvenience this may cause. Mentor stands confidently behind the safety and quality of the products we supply, and we appreciate your cooperation in this matter. Please know the U.S. Food and Drug Administration (FDA) has been notified of this voluntary field action. If you have any questions related to this notice, please contact your local Mentor Sales Representative or Mentor Customer Service at 1-800-235-5731. For further questions please call (972) 252-6060. Thank you for your attention and cooperation.
Recall details
- Recall number
- Z-2070-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 27, 2017
- Posted by the FDA
- May 11, 2017
- Recalling firm
- Mentor Texas, LP.
- Quantity
- 28 units
- Product code
- FWM
- FDA submissions
- P990075
- Distribution
- US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
Product description
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Code information (models, lots, serial numbers)
Lot Number: 7377332
Other devices under the same FDA submission
105 devices cleared under P990075 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MENTOR Smooth Round Moderate Profile 3501650Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline2,187 reports
- MENTOR Smooth Round Moderate Profile 3501660Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,972 reports
- MENTOR Smooth Round Moderate Profile 3501670Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,899 reports
- MENTOR Smooth Round Moderate Profile 3501645Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,655 reports
- MENTOR Smooth Round Moderate Profile 3501655Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,534 reports
- MENTOR Smooth Round Moderate Profile 3501640Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,294 reports
- MENTOR Smooth Round Moderate Profile 3501680Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline1,095 reports
- MENTOR Smooth Round Moderate Profile 3501635Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline864 reports
- MENTOR Smooth Round High Profile 3503330Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline679 reports
- MENTOR Smooth Round Moderate Plus Profile 3502350Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline672 reports
- MENTOR Smooth Round High Profile 3503380Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline672 reports
- MENTOR Smooth Round Moderate Profile 3501685Mentor Texas L.P. · Prosthesis, breast, inflatable, internal, saline623 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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