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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.
Recalled May 1, 2019 · FDA recall Z-1214-2019 · TriMed
Hazard
The bone screw is shorter than the intended design specification. · FDA Class II
Units
13 screws
Sold at
US Distribution to states of FL and MO.
Description
The bone screw is shorter than the intended design specification.
Product
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.
Manufacturer(s)
TriMed Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →