FDA-Device2023-02-15Class II
RipCord Syndesmosis Button, REF: STA001K
TriMed Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS
Affected count
76
Manufactured in
27533 Avenue Hopkins, Santa Clarita, CA, United States
Products
RipCord Syndesmosis Button, REF: STA001K
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2023Don't want to check this manually?
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