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LEGION recallZ-0282-2025 · Smith & Nephew Inc · initiated Oct 2, 2024

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.

FDA root cause category: Packaging change control

What the company is doing

Smith & Nephew issued an "Urgent Medical Device RECALL Notice" to its consignees on 10/02/2024 via email. The notice explained the issue, potential risk of use of the affected product, and requested the return of the affected devices. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 1450 E Brooks Road, Building G | Memphis, TN 38116 Distributors, sales reps, and district offices were directed to notify their customers. If you have any questions or concerns regarding this recall, please contact FieldActions@smith nephew.com.

Recall details

Recall number
Z-0282-2025
Status
Open, Classified
Initiated by the company
Oct 2, 2024
Posted by the FDA
Oct 31, 2024
Recalling firm
Smith & Nephew Inc
Quantity
8 units
Product code
JWH
FDA submissions
K112941
Distribution
US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada

Product description

smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic

Code information (models, lots, serial numbers)

UDI/DI 00885556234204, Batch number 23LM02905

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

14 devices cleared under K112941 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95494).

Sources and updates

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