Z-1951-2021Class II

LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral...

Name: Z-1951-2021 LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral...
Creator: Smith & Nephew, Inc.
Published: 2021-05-19
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2021-05-19 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only... on 2021-05-19. FDA classified it as Class II and gives the reason as "The device components experienced a manufacturing process error that resulted in surface damage from product handling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1951-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-19
Posted: 2021-06-24
Terminated: 2023-04-14
Recalling firm: Smith & Nephew, Inc.
Product: LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 5/19/2021, the firm issued letters dated 5/19/2021 via overnight mail or via email explaining the issue, potential risk of use of the product, and required actions, which are listed on the response form.
Quantity in commerce: 5 units
Distribution: US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
Product codes and lots: Lot 20HM17607

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1951-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1951-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-30	2021-06-24

Product code JWH

K043440Class IISmith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. / cleared 2005-02-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)