TriMed Threaded IM Nails Recalled Due to Out-of-Spec Driver-Socket Defect
TriMed Threaded IM Nail 3.6mm implants are being recalled due to a driver-socket defect that could prevent proper nail pickup or torque application. The recall affects 120 units from lot QM23087 distributed nationwide.
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 medical device recall involving a functional defect in a surgical tool. While no injuries or illnesses are reported, the defect creates a risk-of-harm situation where the driver-socket malfunction could compromise surgical placement of an orthopedic implant. Per the rubric, risk-of-harm products where injury has not yet been reported score as High.
Plain-English summary
TriMed Inc. is recalling 120 units of Threaded IM Nail 3.6mm surgical implants (available in 60mm and 65mm lengths) from lot QM23087 (UDI: 00842188127885). The nails contain a driver-socket that does not meet specifications and could prevent proper pickup of nails or application of sufficient torque during surgical implantation.
The affected lot was distributed nationwide to healthcare facilities in Alaska, Arizona, Arkansas, California, Florida, Hawaii, Illinois, Louisiana, Massachusetts, Michigan, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
Healthcare providers who possess this product should verify their inventory against the affected lot number and take appropriate steps to prevent use in patient care.
The recalled product
- Product
- 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
- Manufacturer
- TriMed Inc.
- Affected units
- 120
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 (1)
- UDI:00842188127885/ Lot # QM23087
Distribution
Part of a larger recall action
This product is one of 2 recalled by TriMed Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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