Mentor Texas, LP. recalls Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 0008…
- Recall date
- March 27, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2070-2017
- FDA classification
- Class II
- Brand / firm
- Mentor Texas, LP.
- Sold / distributed
- US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
Why it was recalled
Missing Dome Pack accessory.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
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