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Terminated

Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000.

FDA Recall Z-0021-05 · Posted 2004-10-19

Recalling FirmStryker Instruments, Instruments Div.
Recall StatusTerminated
Product CodeHAW
Date Initiated2004-07-14
Date Terminated2004-10-18

Reason for Recall

The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.

Firm Action

Sales force was notified these pre-launch devices are not to be used for surgical use via e-mail and telephone calls on 7/14/04.

Root Cause

Other

Distribution Pattern

United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022365STRYKER NAVIGATION SYSTEM - HIP MODULEStryker Instruments · 2003-01-22

Official Source

View FDA Recall →

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

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