Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Reported: May 17, 2017 Initiated: March 27, 2017 #Z-2070-2017
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.
Details
- Recalling Firm
- Mentor Texas, LP.
- Units Affected
- 28 units
- Distribution
- US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048. Recalled by Mentor Texas, LP.. Units affected: 28 units.
Why was this product recalled? ▼
Missing Dome Pack accessory.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2017. Severity: Moderate. Recall number: Z-2070-2017.
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