FDA recall Z-1791-2024

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

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.

Key facts

Status

Ongoing

Initiation date

2024-03-19

Report date

2024-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1791-2024