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Recall Observatory FDA recall evidence

Device product

RipCord Syndesmosis Button, REF: STA001K

Z-1101-2023

December 22, 2022

Class II

Product summary

Firm
TriMed Inc.
Event
Event 91478
Status
Ongoing
Classification
Class II
Quantity
76
Official record key
device-enforcement:Z-1101-2023

Official wording

Reason: 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.

Code information: UDI-DI: 00842188123849, Lot: 85305-01

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.