Biomet, Inc. recalls Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachmen…

Recall date

June 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1945-2015

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures