Z-2445-2008

Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031...

Name: Z-2445-2008 Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031...
Creator: Zimmer Inc.
Published: 2007-08-06
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-08-06 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument on 2007-08-06. The reason FDA records is "Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2445-2008
Status: Terminated
Initiated: 2007-08-06
Posted: 2008-09-20
Terminated: 2009-03-11
Recalling firm: Zimmer GmbH
Product: Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection.
Root cause tag: design
FDA root cause: Device Design
Action: Firm's sales representatives were notified via e-mail on 8/6/07 to review their inventory and that of their accounts and to notify the firm of their location so that they could be replaced. Contact the firm by telephone at 574-267-6131 for additional information concerning this recall.
Quantity in commerce: 39
Distribution: Nationwide Distribution including states of California, Florida and Washington.
Product codes and lots: Lots 050433, BP050199, BP050258 and BP050350.

Product code HAW

K030827Class IINavitrack System: Total Hip Replacement CT-Free Cup, Model 900.204Orthosoft, Inc. / cleared 2003-05-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)