Recall Z-1101-2023— TriMed Inc.

Name: FDA recall Z-1101-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-22

Class II · Ongoing

Class II FDA medical device recall by TriMed Inc., initiated 2022-12-22. It names one FDA 510(k) clearance: K220650. Product: RipCord Syndesmosis Button, REF: STA001K. 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..

Recalling firm: TriMed Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-22
Firm location: Santa Clarita, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K220650 — TriMed Ripcord DeviceTriMed, Inc.·cleared 2022-06-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

RipCord Syndesmosis Button, REF: STA001K

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.