Recall Z-2070-2017— Mentor Texas, LP.
Class II · Terminated
Class II FDA medical device recall by Mentor Texas, LP., initiated 2017-03-27, terminated 2017-06-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048. Reason: Missing Dome Pack accessory..
- Recalling firm
- Mentor Texas, LP.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-27
- Terminated
- 2017-06-13
- Firm location
- Irving, TX, United States
Product description
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Reason for recall
Missing Dome Pack accessory.
Data sourced from openFDA. This site is unofficial and independent of the FDA.