Recall Z-1214-2019— TriMed Inc.

Name: FDA recall Z-1214-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-24

Class II · Terminated

Class II FDA medical device recall by TriMed Inc., initiated 2018-08-24, terminated 2020-12-28. It names one FDA 510(k) clearance: K060041. 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: The bone screw is shorter than the intended design specification..

Recalling firm: TriMed Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-24
Terminated: 2020-12-28
Firm location: Santa Clarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K060041 — TRIMED BONE PLATESTriMed, Inc.·cleared 2006-02-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

The bone screw is shorter than the intended design specification.

Data sourced from openFDA. This site is unofficial and independent of the FDA.