Z-0281-2025Class II

smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated...

Name: Z-0281-2025 smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated...
Creator: Smith & Nephew Inc
Published: 2024-10-02
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2024-10-02 / Open, Classified / root cause: packaging

FDA source

Smith & Nephew Inc began a recall of smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic on 2024-10-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0281-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-02
Posted: 2024-10-31
Recalling firm: Smith & Nephew, Inc.
Product: smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: 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.
Quantity in commerce: 5 units
Distribution: US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
Product codes and lots: UDI/DI 03596010469212, Batch number 23LM02331

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0281-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0281-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-31
Z-0282-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-31

Product code JWH

K962557Class IIGenesis II Zirconium Femoral Component/profix Zirconium Femoral ComponentSmith & Nephew Richards, Inc. / cleared 1996-12-05

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)