EVOS recallZ-0363-2022 · Smith & Nephew, Inc. · initiated Nov 1, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm initiated the correction by email and letter on 1 NOV 2021. The notice explained the problem and requested that the consignees check their inventory and complete the Inventory Correction Certificate form. Distributors were directed to notify their customers of the field action and ensure that these actions are carried out.
Recall details
- Recall number
- Z-0363-2022
- Status
- Terminated
- Initiated by the company
- Nov 1, 2021
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 38 units
- Product code
- HRS
- FDA submissions
- K201918
- Distribution
- US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.
Product description
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Code information (models, lots, serial numbers)
Batch Number: 20HM10249, 20HM10250, 20HM10251, 20HM22783, UDI (01) 00885556752999 (17) 310630 (10) 12345678 (11) 2210630 (21) 87654321
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EVOS 72573101Smith & Nephew, Inc. · Plate, fixation, bone1 recall0 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K201918 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- EVOS 72562010Smith & Nephew, Inc. · Plate, fixation, bone1 report
- EVOS 72573202Smith & Nephew, Inc. · Plate, fixation, bone1 report
- EVOS 72574211Smith & Nephew, Inc. · Plate, fixation, bone1 report
- EVOS 72574217Smith & Nephew, Inc. · Plate, fixation, bone1 report
- EVOS 72572212NSmith & Nephew, Inc. · Plate, fixation, bone1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 89031).
- Z-0364-2022 · Terminatedsmith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201
- Z-0365-2022 · Terminatedsmith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
- Z-0366-2022 · Terminatedsmith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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