Medical device recalls Moderate risk

Boston Scientific Corporation recalls PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ p…

Recall date
February 12, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1624-2018
FDA classification
Class II
Brand / firm
Boston Scientific Corporation
Sold / distributed
Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic,…

What was recalled

PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

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