Recall Z-0772-2021 ยท JDS Nail, Fixation, Bone
Smith & Nephew, Inc.
Bone fixation nail. TRIGEN INTERTAN - Product Usage: indicated for fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fracture;
| Date | Nov 2, 2020 |
| Status | Terminated |
| Reason | Manufacturing packaging error. |
| Root cause | Packaging process control |
| Action | On 11/02/2020 the firm send a letter to its consignees with the following instructions: Required Actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location below. 3. If |
| Quantity | 41 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, KY, MI, NC, NJ, OH, PA, TN, TX, WA and the countries of AU, CA & GB. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040212 | TRIGEN INTERTAN Smith & Nephew, Inc., Feb 20, 2004 |