CLASS II Device recall · Reported 17 May 2017 · FDA Enforcement Report

Mentor Smooth Round Spectrum Post- Operatively Adjustable recalled

Mentor Texas is recalling Mentor Smooth Round Spectrum Post- Operatively Adjustable Saline Breast Implant, distributed in 9 states. The recall was initiated on 27 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 7377332

Quantity recalled28 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2070-2017
FDA event ID: 76868
Recalling firm: Mentor Texas, Irving, TX
Classification: Class II
Status: Terminated
Recall initiated: 27 Mar 2017
FDA classified: 11 May 2017
Reported: 17 May 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Breast Implants

Timeline

27 Mar 2017	Recall initiated by company
11 May 2017	Classified by FDA	+45 days
17 May 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Missing Dome Pack accessory.

Product as listed by the FDA

Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

Where it was distributed

US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.

California Connecticut Illinois Indiana Michigan North Carolina New York Ohio Oklahoma

Questions about this recall

Why was it recalled?

Missing Dome Pack accessory.

Which lots are affected?

Lot Number: 7377332

Where was it sold?

US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Reported	Class	Recall	Company	Reason	Where
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	Artoura Breast Tissue Expanders Reference Numbers recalled	Mentor Texas	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	BBraun Medical Winged INF recalled	B Braun Medical	Device Malfunction	Nationwide
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