RipCord Syndesmosis Button, REF: STA001K
Reported: February 15, 2023 Initiated: December 22, 2022 #Z-1101-2023
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.
Details
- Recalling Firm
- TriMed Inc.
- Units Affected
- 76
- Distribution
- US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS
- Location
- Santa Clarita, CA
Frequently Asked Questions
What product was recalled? ▼
RipCord Syndesmosis Button, REF: STA001K. Recalled by TriMed Inc.. Units affected: 76.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2023. Severity: Moderate. Recall number: Z-1101-2023.
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