TriMed Hex Cortical Screw 4 recalled over sterility concerns

Recall date

August 24, 2018

Source

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

Official notice title

TriMed Inc. recalls TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System.…

Recall number

Z-1214-2019

FDA classification

Class II

Brand / firm

TriMed Inc.

Sold / distributed

US Distribution to states of FL and MO.

Why it was recalled

The bone screw is shorter than the intended design specification.

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 Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.