FDA Device Recall Z-0020-05: Stryker Instruments, Instruments Div.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0020-05.

Recall Res Number

Z-0020-05

Recalling Firm / Manufacturer

Stryker Instruments, Instruments Div.

FEI Number

1811755

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-07-14

Date Posted

2004-10-19

Date Terminated

2004-10-18

Product Code

HAW

Event Number

29675

Product Quantity

N/A

Product Description Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.

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

Action Details 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.

Distribution Pattern United States.

Code Information / Serial Numbers Serial numbers PG04-0001 through PG04-0017.

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Medical Device Recall: Z-0020-05

Recall Parameters & Description

Related Establishments / Registrations

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