Z-0108-06

Reliance PF Femoral Stem

Name: Z-0108-06 Reliance PF Femoral Stem
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-08-24
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-08-24 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Reliance PF Femoral Stem on 2005-08-24. The reason FDA records is "The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0108-06
Status: Terminated
Initiated: 2005-08-24
Posted: 2005-11-01
Terminated: 2006-04-05
Recalling firm: Howmedica Osteonics Corp
Product: Reliance PF Femoral Stem
Product code: MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Reason for recall: The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.
FDA root cause: Other
Action: A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.
Quantity in commerce: 8487 units
Distribution: nationwide
Product codes and lots: Catalog #---Description---- # of lots: 6265-2-000, Reliance PF Hip #0/10MM, 386 lots; 6265-2-001, Reliance PF Hip #1/11MM, 484 lots; 6265-2-002, Reliance PF Hip #2/12MM, 617 lots; 6265-2-003, Reliance PF Hip #3/13MM, 692 lots; 6265-2-004, Reliance PF Hip #4/14MM, 465 lots; 6265-2-005, Reliance PF Hip #5/15MM, 299 lots; 6265-2-006, Reliance PF Hip #6/16MM, 184 lots; 6265-2-007, Reliance PF Hip #7/17MM, 138 lots.

Product code MAY

K970200Class IIReliance Pf Femoral StemsHowmedica Corp. / cleared 1997-04-09

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)