Z-0448-2014Class II

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith &...

Name: Z-0448-2014 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith &...
Creator: Smith & Nephew Inc
Published: 2013-08-27
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-08-27 / Terminated / root cause: packaging

FDA source

Smith & Nephew Inc began a recall of GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic on 2013-08-27. FDA classified it as Class II and gives the reason as "The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0448-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-27
Posted: 2013-12-04
Terminated: 2019-08-20
Recalling firm: Smith & Nephew, Inc.
Product: GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Smith & Nephew sent an Urgent Recall Notification letter dated August 27, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. They were instructed to cease use and distribution of the product and quarantine for return. Customers were instructed to contact Smith & Nephew via email at [email protected] or fax 901-566-7975 to obtain a return authorization (RA) number. Customers with questions were also instructed use this email address. Customers with affected product were instructed to return it along with the completed inventory Return Certification Form to the address listed on the form. Non-responding consignees were notified again on September 27, 2013, by email. For questions regarding this recall call 901-396-2121.
Quantity in commerce: 46 pieces
Distribution: Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.
Product codes and lots: Batch No. 12GT20775

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0448-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0444-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04
Z-0445-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04
Z-0446-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04
Z-0447-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04
Z-0448-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04
Z-0449-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04

Product code JWH

K032295Class IIGenesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc. / cleared 2003-08-21

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)