TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65m

FDA device recall Z-1791-2024 · posted 2024-05-10 · Open, Classified

Recall details

Recalling firm

TriMed Inc.

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.

Action taken

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: Quality@trimedortho.com. 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.

Root cause

Process control

Status

Open, Classified

Product code

HWC

Quantity affected

142 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.

Date initiated

2024-03-19

Date posted

2024-05-10

Location

Santa Clarita, CA

Related 510(k) clearances