Z-2883-2018Class II

GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis

Name: Z-2883-2018 GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Creator: Smith & Nephew, Inc.
Published: 2017-08-01
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-08-01 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis on 2017-08-01. FDA classified it as Class II and gives the reason as "Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left". 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-2883-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-01
Posted: 2018-08-22
Terminated: 2019-02-19
Recalling firm: Smith & Nephew, Inc.
Product: GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm notified its consignees of the problem and the recall by email on 08/01/2018. The firm requested the return of the product.
Quantity in commerce: 27 units
Distribution: Australia, Austria, Germany, Great Britain, Poland, Spain
Product codes and lots: Lot Numbers: 16CMB0061A, 16CMB0066A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2883-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2883-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-29	2018-08-22

Product code JWH

K951987Class IIGenesis II Total Knee SystemSmith & Nephew Richards, Inc. / cleared 1995-08-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)