Recall Z-2070-2017 ยท FWM Prosthesis, Breast, Inflatable, Internal, Saline
Mentor Texas, LP.
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
| Date | May 11, 2017 (initiated Mar 27, 2017) |
| Status | Terminated |
| Reason | Missing Dome Pack accessory. |
| 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 inve |
| Quantity | 28 units |
| Distribution | US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.