Z-1996-2013Class II

Genesis(r) II Cruciate Retaining Articular Insert, Trial, Size 3-4, A/p 48 Mm, M/l 68 Mm, Qty 1, Non-Sterile...

Name: Z-1996-2013 Genesis(r) II Cruciate Retaining Articular Insert, Trial, Size 3-4, A/p 48 Mm, M/l 68 Mm, Qty 1, Non-Sterile...
Creator: Smith & Nephew Inc
Published: 2013-07-08
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2013-07-08 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew Inc began a recall of GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic on 2013-07-08. FDA classified it as Class II and gives the reason as "The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1996-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Posted: 2013-08-22
Terminated: 2019-08-19
Recalling firm: Smith & Nephew, Inc.
Product: GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Smith & Nephew sent an Urgent Recall Notification letter dated July 8, 2013 to all affected customers. Surgeons were notified by letter beginning on July 16, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, locate unused devices, quarantine immediately, and return affected product to the address provided in the notification. For questions email to [email protected].
Quantity in commerce: 9 units
Distribution: International only: Germany, France, United Arab Emirates, and United Kingdom.
Product codes and lots: Lot Number 12LM03798

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1996-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1996-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-28	2013-08-21

Product code JWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)