Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081

FDA device recall Z-2070-2017 · posted 2017-05-11 · Terminated

Recall details

Recalling firm

Mentor Texas, LP.

Reason for recall

Missing Dome Pack accessory.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FWM

Quantity affected

28 units

Distribution

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

Date initiated

2017-03-27

Date posted

2017-05-11

Date terminated

2017-06-13

Location

Irving, TX