FDA-Device2013-12-04Class II
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
Synthes USA HQ, Inc.
Hazard
All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
Sold states
Worldwide Distribution - USA (nationwide) and internationally to Canada.
Affected count
40248
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0390-2014Don't want to check this manually?
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