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Synthes USA HQ, Inc. recalls 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combinat
Recalled December 4, 2013 · FDA recall Z-0390-2014 · Synthes USA HQ
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. · FDA Class II
Units
40248
Sold at
Worldwide Distribution - USA (nationwide) and internationally to Canada.
Description
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.
Product
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.
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →