TriMed Inc.: Medical Device Recall in 2019 - (Recall #: Z-1214-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 24, 2018

Date Posted: May 1, 2019

Recall Number: Z-1214-2019

Event ID: 82209

Reason for Recall:

The bone screw is shorter than the intended design specification.

Status: Terminated

Product Quantity: 13 screws

Code Information:

Lot #170281, UDI (01)00842188107108(11)170406(10)170281

Distribution Pattern:

US Distribution to states of FL and MO.

Voluntary or Mandated:

Voluntary: Firm initiated