Z-2070-2017Class II

Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant

Name: Z-2070-2017 Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant
Creator: Mentor Texas, LP.
Published: 2017-03-27
License: https://open.fda.gov/license/

Mentor / initiated 2017-03-27 / Terminated

FDA source

Mentor Texas, LP. began a recall of Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048 on 2017-03-27. FDA classified it as Class II and gives the reason as "Missing Dome Pack accessory". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2070-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-27
Posted: 2017-05-11
Terminated: 2017-06-13
Recalling firm: Mentor
Product: Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Product code: FWM Prosthesis, Breast, Inflatable, Internal, Saline
Reason for recall: Missing Dome Pack accessory.
FDA root cause: Other
Action: 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.
Quantity in commerce: 28 units
Distribution: US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
Product codes and lots: Lot Number: 7377332

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2070-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2070-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-11

Product code FWM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)