Medical device recalls Moderate risk

TriMed Inc. recalls 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…

Recall date
March 19, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1791-2024
FDA classification
Class II
Brand / firm
TriMed Inc.
Sold / distributed
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.

Why it was recalled

Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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