Z-2055-2008

OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended...

Name: Z-2055-2008 OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-03-09
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-03-09 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or... on 2005-03-09. The reason FDA records is "The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2055-2008
Status: Terminated
Initiated: 2005-03-09
Posted: 2008-09-16
Terminated: 2008-09-24
Recalling firm: Howmedica Osteonics Corp
Product: OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
Product code: HWT Template
Reason for recall: The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Notification letters and Product Accountability Forms were sent to consignees via Fed-ex on March 9, 2005 with return receipt. An advisory notice was sent to Canada and International distributors on March 9, 2005. For information on this recall, contact Rita Intorrella at 201-831-5825 or Greg Schack at 201-831-5399.
Quantity in commerce: Sell sheets: 1919, Cutting Edge Advantage Brochure: 810
Distribution: Worldwide
Product codes and lots: Literature number: LHFX-SS rev 1; Cutting Edge Advantage Brochure w/inserts, Literature Number: LCEA-B

Product code HWT

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)