Summary
The FDA issued a Class II for RipCord Syndesmosis Button, REF: STA001K by TriMed Inc.. 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 excee.
Details
Source
Device Recall
External ID
Z-1101-2023
Action Date
2023-02-15
Status
Ongoing
Category
device
Product Description
RipCord Syndesmosis Button, REF: STA001K
Lot/Code Info: UDI-DI: 00842188123849, Lot: 85305-01
Quantity Affected: 76
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.
Distribution
US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-22
Company
Santa Clarita, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TriMed Inc. has 24 FDA actions in our database, including 4 recalls and 20 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TriMed Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TriMed Inc. have FDA actions?
TriMed Inc. has 24 FDA actions in our database, including 4 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1101-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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