Z-1601-2010

Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used to centralize the...

Name: Z-1601-2010 Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used to centralize the...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2010-03-29
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-03-29 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used to centralize the femoral stem within the intramedullary canal... on 2010-03-29. The reason FDA records is "Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label". 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-1601-2010
Status: Terminated
Initiated: 2010-03-29
Posted: 2010-05-13
Terminated: 2012-09-10
Recalling firm: Howmedica Osteonics Corp
Product: Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920. Intended to be used to centralize the femoral stem within the intramedullary canal. intended to be used with bone cement.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Stryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Urgent Product Recall letters and Product Accountability Forms have been sent via Fed Ex on March 29, 2010 with return receipt. Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeon were also sent Notification letters and Product Recall Acknowledgment Form on March 29, 2010 with return receipt. The letters explained the issue, the potential hazards, and risk mitigation. The firm asked customers to examine their inventory and hospital locations to identify the affected products. All affected product should be retrieved and returned to their branch or agency warehouse for reconciliation. The attached Product Accountability form should be used to reconcile all product(s) and it should be faxed back to 201-831-6069.
Quantity in commerce: 24 units
Distribution: Nationwide Distribution -- FL, MN, & OR.
Product codes and lots: Lot code - L3988

Product code JDI

K974054Class IIDistal Centralizer, Exeter II Hip SystemHowmedica, Inc. / cleared 1997-12-23

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)