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Biomet, Inc. recalls Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattach
Recalled July 8, 2015 · FDA recall Z-1945-2015 · Biomet
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. · FDA Class II
Units
41 units
Sold at
Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
Description
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.
Product
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
Manufacturer(s)
Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →