Z-0854-03

Interax Knee Midi 1 Tibial Inserts. IX HC Tib Bear Ins M1 14mm R

Name: Z-0854-03 Interax Knee Midi 1 Tibial Inserts. IX HC Tib Bear Ins M1 14mm R
Creator: Stryker Howmedica Osteonics
Published: 2003-01-23
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2003-01-23 / Terminated

FDA source

Stryker Howmedica Osteonics began a recall of Interax Knee Midi 1 Tibial Inserts. IX HC Tib Bear Ins M1 14mm R on 2003-01-23. The reason FDA records is "The device is demonstrating early wear and delamination". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0854-03
Status: Terminated
Initiated: 2003-01-23
Posted: 2003-05-21
Terminated: 2004-12-01
Recalling firm: Howmedica Osteonics Corp
Product: Interax Knee Midi 1 Tibial Inserts. IX HC Tib Bear Ins M1 14mm R.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The device is demonstrating early wear and delamination.
FDA root cause: Other
Action: Recall letters were sent to the Howmedica branches and hospitals on January 23, 2003 via FedEx.
Quantity in commerce: 10
Distribution: Howmedica distributed this device to 2 Howmedica branches and 3 hospitals are Parkview Episcopal Hospital, Pueblo, CO; St. Mary Corwin Hospital, Pueblo, CO; and Hement Valley Hospital, Riverside, CA.
Product codes and lots: Catalog No. 66402135 Lot: L8YW; LYAU

Product code JWH

K973121Class IIInterax Total Knee SystemHowmedica Corp. / cleared 1997-11-18

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)