Z-0557-2010

Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper...

Name: Z-0557-2010 Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-01-14
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-01-14 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads on 2009-01-14. The reason FDA records is "Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument". 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-0557-2010
Status: Terminated
Initiated: 2009-01-14
Posted: 2009-12-22
Terminated: 2012-07-18
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.
Quantity in commerce: 786 total stems
Distribution: Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.
Product codes and lots: Catalog Number: J6054-XXXX; All lots codes with an expiry prior to Aug. 2013.

Product code MEH

K020615Class IISuper Secur-Fit Ha Hip Stems and Super Secur-Fit Plus Ha Hip StemsHowmedica Osteonics Corp. / cleared 2002-05-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)