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 l…

Recall date

August 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2849-2016

FDA classification

Class II

Brand / firm

Trimed Inc

Sold / distributed

Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.