Z-2621-2023Class II

smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF...

Name: Z-2621-2023 smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF...
Creator: Smith & Nephew Inc
Published: 2023-08-31
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2023-08-31 / Open, Classified / root cause: labeling and UDI

FDA source

Smith & Nephew Inc began a recall of smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint on 2023-08-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2621-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-31
Posted: 2023-09-20
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 8 units
Distribution: OH, CT, TX, NC, CA, NE, NV
Product codes and lots: UDI/DI: 00885556234006, Lot Number: 23EM09878

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2621-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2621-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-20

Product code JWH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)