Recall Z-2685-2020 ยท JDS Nail, Fixation, Bone
Smith & Nephew, Inc.
TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.
| Date | Jun 24, 2020 |
| Status | Terminated |
| Reason | A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve. |
| Root cause | Reprocessing Controls |
| Action | On 06/24/2020 the firm sent an email 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 locati |
| Quantity | 12 units |
| Distribution | International distribution in the countries of Brazil, Colombia and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061019 | TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS Smith & Nephew, Inc., Jun 6, 2006 |