Z-1791-2024 Class II Ongoing
FDA device recall Z-1791-2024 was initiated by TriMed Inc. on March 19, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 142 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- March 19, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 142 units
Product Description
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 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.
Code Information
UDI: 00842188127878/ Lot # QM23086