TriMed Inc. recalls RipCord Syndesmosis Button, REF: STA001K

Recall date

December 22, 2022

Source

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

Recall number

Z-1101-2023

FDA classification

Class II

Brand / firm

TriMed Inc.

Sold / distributed

US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS

Why it was recalled

Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

RipCord Syndesmosis Button, REF: STA001K