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Trimed Inc recalls TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in
Recalled September 28, 2016 · FDA recall Z-2849-2016 · Trimed
Hazard
TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted. · FDA Class II
Units
30 units
Sold at
Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.
Description
TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.
Product
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.
Manufacturer(s)
Trimed Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →