Recall Z-0318-2027 ยท HRS Plate, Fixation, Bone
Smith & Nephew, Inc.
EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106
| Date | Oct 30, 2026 (initiated Sep 6, 2026) |
| Status | Open, Classified |
| Reason | Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant |
| Root cause | Labeling Change Control |
| Action | On September 3, 2026, Smith & Nephew, Inc. issued a Urgent Medical Device Recall Notice to affected consignees via 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. 1a. 0If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customer s account number and name in Section A. 2. If you have no product to return: a. Please put an X in the appr |
| Quantity | 7 units |
| Distribution | US Nationwide distribution in the states of AZ, NV, TX, NM, WA, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170457 | EVOS Small Fragment Lower Extremity Plates Smith & Nephew, Inc., Jun 14, 2017 |
| K210837 | Smith & Nephew Plates and Screws Smith & Nephew, Inc., Jun 29, 2021 |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS) Smith & Nephew, Inc., Sep 29, 2022 |