RipCord Syndesmosis Button suture may break during orthopedic surgery
The RipCord Syndesmosis Button's pull suture can break when excessive tension is applied during orthopedic surgery. TriMed Inc. is recalling 76 units due to this structural failure risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a medical device with no reported adverse events or injuries. The hazard involves potential suture breakage during orthopedic surgery, which poses a risk to patient safety but has not resulted in reported harm, qualifying this as a High severity risk-of-harm product.
Plain-English summary
TriMed Inc. is recalling the RipCord Syndesmosis Button (Model STA001K, Lot 85305-01), a surgical device used in orthopedic procedures to treat syndesmosis injuries. The recall affects 76 units distributed nationwide.
The device's pull suture can break when exposed to overly aggressive tension during surgery, specifically when passing the medial button through a bone and soft tissue tunnel across the fibula and tibia. This structural failure could compromise the surgical repair and result in patient complications.
Patients and healthcare providers should contact TriMed Inc. with questions or to report any adverse events. If you have received this device and experience complications related to the surgical repair, inform your healthcare provider immediately.
The recalled product
- Product
- RipCord Syndesmosis Button, REF: STA001K
- Manufacturer
- TriMed Inc.
- Affected units
- 76
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00842188123849
- Lot: 85305-01
Distribution
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