Z-0467-03

Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218

Name: Z-0467-03 Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218
Creator: Stryker Howmedica Osteonics
Published: 2002-12-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2002-12-02 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics began a recall of Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218 on 2002-12-02. The reason FDA records is "Product mix-up. 16mm stem in a 18mm package". 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-0467-03
Status: Terminated
Initiated: 2002-12-02
Posted: 2003-01-28
Terminated: 2003-08-01
Recalling firm: Howmedica Osteonics Corp
Product: Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Product mix-up. 16mm stem in a 18mm package.
Root cause tag: packaging
FDA root cause: Other
Action: Branches and agents were notified via letter on 12/2/2002. Hospitals were notified on 12/2/2002 via FedEx to OR Supervisors.
Quantity in commerce: 6
Distribution: The product was shipped to 2 Howmedica branches, 1 hospital, one government hospital, and 2 international distributors. Government hospital is the VA Medical Center, Tampa, FL.. Two international customers are Stryker Howmedica affiliates in Chile and Spain.
Product codes and lots: Catalog No. 6013-1216 -- Lot Code: 37778302; Catalog No. 6013-1218 -- Lot Code: 37778401.

Product code MEH

K944836Class IIOsteonics Restoration Monolithic II Hip Stem SeriesOsteonics Corp. / cleared 1995-04-10

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)