FDA-Device2015-07-08Class II
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
Biomet, Inc.
Hazard
Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.
Sold states
Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
Affected count
41 units
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1945-2015Don't want to check this manually?
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