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Synthes (USA) Products LLC recalls Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, t
Recalled September 30, 2015 · FDA recall Z-2794-2015 · Synthes (USA) Products
Hazard
DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head. · FDA Class II
Units
40038
Sold at
Nationwide Distribution
Description
DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014, related to complaints of breakage located at the bottom of the screws and under the locking screw head.
Product
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; 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) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →