Z-1158-06

Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 left, Part No. 71420136

Name: Z-1158-06 Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 left, Part No. 71420136
Creator: Smith & Nephew Inc
Published: 2006-04-12
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2006-04-12 / Terminated / root cause: packaging

FDA source

Smith & Nephew Inc began a recall of Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 left, Part No. 71420136 on 2006-04-12. The reason FDA records is "Mispackaging-A size 5 femoral component, right, box had a size 5 left component in the box". 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-1158-06
Status: Terminated
Initiated: 2006-04-12
Posted: 2006-06-17
Terminated: 2007-04-11
Recalling firm: Smith & Nephew, Inc.
Product: Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 left, Part No. 71420136
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Reason for recall: Mispackaging-A size 5 femoral component, right, box had a size 5 left component in the box.
Root cause tag: packaging
FDA root cause: Other
Action: All consignees were notified of the potential swap on 4/11/2006 via phone. The firm followed with a recall notice dated 05/18/2006.
Quantity in commerce: 4 units
Distribution: Worldwide-including states of LA, NC, IN, and countries of France, and Turkey
Product codes and lots: 05KM06224

Product code HSX

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)