Z-0794-2010

Navigation Reamer T-handle; Non Sterile; Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430. Intended...

Name: Z-0794-2010 Navigation Reamer T-handle; Non Sterile; Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430. Intended...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-08-08
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-08-08 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Navigation Reamer T-handle; Non Sterile; Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430. Intended for use in orthopaedic surgery to interface with... on 2005-08-08. The reason FDA records is "Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly". 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-0794-2010
Status: Terminated
Initiated: 2005-08-08
Posted: 2010-02-17
Terminated: 2010-02-18
Recalling firm: Howmedica Osteonics Corp
Product: Navigation Reamer T-handle; Non Sterile; Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430. Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers.
Product code: HTO Reamer
Reason for recall: Stryker Orthopaedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Orthopaedics issued notification dated August 8, 2005 via Federal Express. Consignees were informed of the affected product and necessary steps to take for product replacement. For further information, contact Stryker at (201) 831-5825.
Quantity in commerce: 22
Distribution: Worldwide Distribution -- United States, Germany, The Netherlands, Spain, Italy, Switzerland, Poland, Romania, South Africa, England, Columbia, Venezuela, Japan and Australia.
Product codes and lots: Catalog Number: 2124-2100; Lot Codes: ALZH05 and ALZE32.

Product code HTO

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)