Recall Z-1101-2023 ยท HTN Washer, Bolt Nut
TriMed Inc.
RipCord Syndesmosis Button, REF: STA001K
| Date | Feb 7, 2023 (initiated Dec 22, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 76 |
| Distribution | US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220650 | TriMed Ripcord Device TriMed, Inc., Jun 1, 2022 |