FDA recall Z-1214-2019

TriMed Inc. · Class II · device

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.

Reason for recall

The bone screw is shorter than the intended design specification.

Distribution

US Distribution to states of FL and MO.

Key facts

Status
Terminated
Initiation date
2018-08-24
Report date
2019-05-01
Termination date
2020-12-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1214-2019