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U.S. Department of Health and Human Services

Class 2 Device Recall SalineFilled SPECTRUM Breast Implants

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 Class 2 Device Recall SalineFilled SPECTRUM Breast Implantssee related information
Date Initiated by FirmMarch 27, 2017
Date PostedMay 11, 2017
Recall Status1 Terminated 3 on June 13, 2017
Recall NumberZ-2070-2017
Recall Event ID 76868
PMA NumberP990075 
Product Classification Prosthesis, breast, inflatable, internal, saline - Product Code FWM
ProductMentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Code Information Lot Number: 7377332
Recalling Firm/
Manufacturer		 Mentor Texas, LP.
3025 Skyway Cir N
Irving TX 75038-3524
For Additional Information Contact
972-252-6060
Manufacturer Reason
for Recall		Missing Dome Pack accessory.
FDA Determined
Cause 2		Other
ActionMentor 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 Commerce28 units
DistributionUS Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = FWM
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