Z-0339-04

Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem

Name: Z-0339-04 Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem
Creator: Plus Orthopedics
Published: 2003-09-19
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2003-09-19 / Terminated / root cause: design

FDA source

Plus Orthopedics began a recall of Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem on 2003-09-19. The reason FDA records is "Design Change". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0339-04
Status: Terminated
Initiated: 2003-09-19
Posted: 2004-01-14
Terminated: 2005-03-03
Recalling firm: Plus Orthopedics
Product: Hip Stem, Sterile Pkg. The implant consists of 2 metal componets which fit together to for a femoral stem.
Product code: LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: Design Change
Root cause tag: design
FDA root cause: Other
Action: Notify all implanting physicians of the removal and weight restrictions, and to evaluate thier patients for adherence to the weight restriction.
Quantity in commerce: 53
Distribution: CA, AZ, NV, NV, CO
Product codes and lots: Catalog numbers, 11911, 11912, 11913, 11914, 11930, 11931

Product code LWJ

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)