Z-0315-2011

Distal Centralizer 10 mm

Name: Z-0315-2011 Distal Centralizer 10 mm
Creator: Ortho Development Corporation
Published: 2010-07-28
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2010-07-28 / Terminated / root cause: manufacturing process

FDA source

Ortho Development Corporation began a recall of Distal Centralizer 10 mm on 2010-07-28. The reason FDA records is "The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper". 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-0315-2011
Status: Terminated
Initiated: 2010-07-28
Posted: 2010-11-03
Terminated: 2010-11-04
Recalling firm: Ortho Development Corp.
Product: Distal Centralizer 10 mm
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ortho Development sent a Field Notification Memo dated July 28, 2010 to Japan Medical Dynamic Marketing instructing them to reconcile parts that may have been used and return unused parts to Ortho. Customers can contact Ortho Development at 1-801-619-3419.
Quantity in commerce: 39 units
Distribution: Worldwide Distribution: Japan
Product codes and lots: Work order numbers: 0050794; 0051535; 0054967; 0055667; 0060372; 0061102; 0061769; 0062929; 0063395

Product code KWY

K962448Class IIPrimaloc Cemented Hip SystemOrtho Development Corp. / cleared 1996-09-19

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)