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-1791-2024
Product summary
- Firm
- TriMed Inc.
- Event
- Event 94381
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 142 units
- Official record key
device-enforcement:Z-1791-2024
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: 00842188127878/ Lot # QM23086
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
out of specification