FDAClass IIFebruary 15, 2023

RipCord Syndesmosis Button recall

RipCord Syndesmosis Button, REF: STA001K

Why was RipCord Syndesmosis Button 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00842188123849, Lot: 85305-01

Product
RipCord Syndesmosis Button, REF: STA001K
Recalling firm
TriMed Inc.
Quantity
76
Distribution
US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS
Recall date
February 15, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls