FDA-Device2015-09-30Class II
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.
Synthes (USA) Products LLC
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.
Sold states
Nationwide Distribution
Affected count
40038
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2794-2015Don't want to check this manually?
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