LEGION recallZ-2621-2023 · Smith & Nephew Inc · initiated Aug 31, 2023
Open, Classified
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
The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
FDA root cause category: Labeling Change Control
What the company is doing
Smith & Nephew issued an Urgent Medical Device3 Recall Notice to its consignees on 08/31/2023 via letter and email. The notice explained the problem and potential risk and requested the consignee quarantine the affected product. Distributors were directed to notify their customers. Firm is seeking return of the affected product.
Recall details
- Recall number
- Z-2621-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 31, 2023
- Posted by the FDA
- Sep 20, 2023
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 8 units
- Product code
- JWH
- FDA submissions
- K230653, K112941
- Distribution
- OH, CT, TX, NC, CA, NE, NV
Product description
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Code information (models, lots, serial numbers)
UDI/DI: 00885556234006, Lot Number: 23EM09878
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LEGION 71421265Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall6 reports
Product lines
Other devices under the same FDA submission
765 devices cleared under K230653, K112941 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- LEGION 71453231Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER88 reports
- JOURNEY 74022125Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall27 reports
- JOURNEY 74027262Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall16 reports
- LEGION 71453211Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER64 reports
- ENGAGE 1-10003-410Smith & Nephew, Inc. · Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall10 reports
- LEGION 71453221Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER59 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
- ENGAGE 1-10012-500Smith & Nephew, Inc. · Prosthesis, knee, femorotibial, unicompartmental/unicondylar, uncemented, porous-coated, metal/polymer1 recall6 reports
- ENGAGE 1-10003-510Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall5 reports
- ENGAGE 1-10012-550Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall5 reports
- LEGION 71421164Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall5 reports
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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