Recall Z-1792-2024 ยท HWC Screw, Fixation, Bone
TriMed Inc.
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
| Date | May 10, 2024 (initiated Mar 19, 2024) |
| Status | Open, Classified |
| Reason | Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque. |
| Root cause | Process control |
| Action | On 4/3/24, TriMed Inc., issued a "Urgent: Medical Device Recall", to affected consignees via E-Mail. TriMed ask consignees to take the following actions: " If you have the affected product, discontinue further use and quarantine products prior to return. " If a successful implantation was completed no further action is necessary. Only standard monitoring of the patient is required after successful implantation. " Please share this notice with all personnel that may utilize the affected products. Please share this notification to any locations where the affected product may have been t |
| Quantity | 120 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K234040 | TriMed Threaded Intramedullary Nail System TriMed, Inc., Jan 18, 2024 |