RipCord Syndesmosis Button, REF: STA001K
FDA Recall #Z-1101-2023 — Class II — December 22, 2022
Product Description
RipCord Syndesmosis Button, REF: STA001K
Reason for Recall
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.
Recalling Firm
TriMed Inc. — Santa Clarita, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
76
Distribution
US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS
Code Information
UDI-DI: 00842188123849, Lot: 85305-01
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated