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Recall Observatory FDA recall evidence

Device 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

Z-1792-2024

March 19, 2024

Class II

Product summary

Firm
TriMed Inc.
Event
Event 94381
Status
Ongoing
Classification
Class II
Quantity
120 units
Official record key
device-enforcement:Z-1792-2024

Official wording

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

Code information: UDI:00842188127885/ Lot # QM23087

Distribution pattern: 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.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification