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Terminated

Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 6mm Lft.

FDA Recall Z-0851-03 · Posted 2003-05-21

Recalling FirmStryker Howmedica Osteonics
Recall StatusTerminated
Product CodeJWH
Date Initiated2003-01-23
Date Terminated2004-12-01
Product Quantity10

Reason for Recall

The device is demonstrating early wear and delamination.

Firm Action

Recall letters were sent to the Howmedica branches and hospitals on January 23, 2003 via FedEx.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973121INTERAX TOTAL KNEE SYSTEMHowmedica Corp. · 1997-11-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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