TriMed recalls RipCord Syndesmosis Button REF STA001K due to risk of button breaking during surgery, potentially causing complications. Affected units have UDI-DI 00842188123849 and Lot 85305-0: stop using immediately.
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.
TriMed is recalling its RipCord Syndesmosis Button (REF: STA001K) because it can break during surgery when tension is applied while passing through bone tunnels. This breakage could cause complications for patients needing orthopedic surgery.
The button can break when excessive tension is applied while passing it through a tunnel in the fibula and tibia bones. This breakage could cause surgical complications, such as tissue damage or incomplete fixation.
Surgical teams using the RipCord Syndesmosis Button for orthopedic procedures are most at risk. Patients undergoing surgery with this device may face complications if it breaks during the procedure.
Check for the product name 'RipCord Syndesmosis Button' with reference number STA001K. Units have UDI-DI 00842188123849 and lot number 85305-01.
The device should be stopped from use immediately as it can break during surgery.
The button can break during surgery when tension is applied while passing through bone tunnels, potentially causing complications.
The product reference number is STA001K.
Check for the product name 'RipCord Syndesmosis Button' with reference number STA001K. Units have UDI-DI 00842188123849 and lot number 85305-01.
We’ve drafted a message you can send TriMed to request your refund or repair — edit it as you like.
Subject: Recall Z-1101-2023 — TriMed TriMed Hello, I own a TriMed that is covered by recall Z-1101-2023 from TriMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
