Skip to content

RipCord Syndesmosis Button, REF: STA001K recallZ-1101-2023 · TriMed Inc. · initiated Dec 22, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from TriMed Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On 12/22/22, Safety Alert/Advisory Notices were emailed to consignees who were told the following: The updated surgical technique can be found at trimedortho.com/surgical-techniques/ This notice needs to be shared with those who need to be aware within your organization. Acknowledgment and Receipt forms were sent with the notices to be filled out and returned to the firm via the email address below. 1. Deliver the suture passer and pull suture (white/blue) through the soft tissue on the medial side. 2. Maintain gentle tension on the sutures while passing the medial button through the tunnel. Wrapping the pull suture around a finger of one hand and holding the device sutures on the opposite side with the other hand helps maintain gentle, continuous tension as the button is passed and maintains alignment of the medial button with the axis of the tunnel. 3. Gently slide the sutures back and forth to ensure that there are no obstructions and that the sutures are aligned with the bone tunnel. 4. Continue to gently oscillate as the medial button starts to engage the hole and proceed with a swift, consistent pull to deliver the medial button out the medial side. Avoid excessive movement of the fibula relative to the tibia which can misalign the bone tunnels. If excessive resistance is felt, withdraw the button and try again. 5. Once the medial button clears the medial cortex pull back on the device suture to seat the button; cut and remove the pull suture. If you have any questions, please contact [email protected] On 2/14/23, recall notices were sent to customers who were asked to do the following: 1) Stop further use of the device and return any unused products to the recalling firm. 2) Provide a copy of this recall notice to the hospital/surgeon/physician that is using the device. 3) Complete and return the response form.

Recall details

Recall number
Z-1101-2023
Status
Open, Classified
Initiated by the company
Dec 22, 2022
Posted by the FDA
Feb 7, 2023
Recalling firm
TriMed Inc.
Quantity
76
Product code
HTN
FDA submissions
K220650
Distribution
US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS

Product description

RipCord Syndesmosis Button, REF: STA001K

Code information (models, lots, serial numbers)

UDI-DI: 00842188123849, Lot: 85305-01

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page