Z-2007-2008

6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325...

Name: Z-2007-2008 6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-12-20
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-12-20 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of... on 2005-12-20. The reason FDA records is "The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2007-2008
Status: Terminated
Initiated: 2005-12-20
Posted: 2008-09-22
Terminated: 2008-09-23
Recalling firm: Howmedica Osteonics Corp
Product: 6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Number: 2030-6525-1 The Omnifit bone screws are intended to augment the fixation of compatible acetabular cups.
Product code: HWC Screw, Fixation, Bone
Reason for recall: The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The recalling firm sent notification letters and Product Accountability Forms via Fed Ex with return receipt on December 20, 2005. The notification letter described the problem, and asked customers to inventory and quarantine the affected product. Customers were told to return the affected product to Stryker. Contact Stryker at 1-201-831-5825 for assistance.
Quantity in commerce: 29 units
Distribution: nationwide
Product codes and lots: Lot Code: 35323605

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)