Z-0130-2014Class II

Genesis(r) II, Non-Porous Tibial Base, Size 5, Left, Qty: (1), Ref 71420168

Name: Z-0130-2014 Genesis(r) II, Non-Porous Tibial Base, Size 5, Left, Qty: (1), Ref 71420168
Creator: Smith & Nephew Inc
Published: 2013-10-07
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-10-07 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic on 2013-10-07. FDA classified it as Class II and gives the reason as "Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa". 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-0130-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-07
Posted: 2013-11-01
Terminated: 2016-08-23
Recalling firm: Smith & Nephew, Inc.
Product: GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Smith & Nephew sent an Urgent - Product Recall 1st Notification letter to all affected sales staff via email and FedEx on October 7, 2013. The hospital was notified by sales rep on October 9, 2013 and the notification letter was sent to the hospital via Fed Ex on October 11, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, discontinue use, quarantine affected products immediately and return to Smith & Nephew. Customers were asked to complete the attached Inventory Return Certification Form and fax to 901-566-7975.
Quantity in commerce: 4 units
Distribution: USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
Product codes and lots: Batch No. 13GM11272

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0130-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0130-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-01
Z-0131-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-01

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)