TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65
Summary
The FDA issued a Class II for TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx by TriMed Inc.. Reason: Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque..
Details
Source
Device Recall
External ID
Z-1792-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
Product Description
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only
Lot/Code Info: UDI:00842188127885/ Lot # QM23087
Quantity Affected: 120 units
Reason for Recall
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
Distribution
US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-19
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 191 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-1792-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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