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
Recall
- Recall Number
- Z-1792-2024
- Event Number
- 94381
- Firm
- TriMed Inc.
- FEI Number
- 3001236812
- Product Code
- HWC
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- March 19, 2024
- Posted
- May 10, 2024
- Address
- 27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910
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
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
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 transferred to. " Conduct a physical count of the affected product in your possession and record the count on attached response form. Once the response form is completed, email to: [email protected]. Please respond even if you have no affected products in your inventory. " Once the response form is completed and emailed, you will receive an RGA (Return Good Authorization form) as well as a link to generate a label to return the devices via email. Please package the devices, print the return label and ship via FedEx.
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.
120 units