Z-2444-2008

Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc...

Name: Z-2444-2008 Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc...
Creator: Zimmer Inc.
Published: 2006-04-27
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2006-04-27 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical... on 2006-04-27. The reason FDA records is "The three-point array 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-2444-2008
Status: Terminated
Initiated: 2006-04-27
Posted: 2008-09-23
Terminated: 2009-03-11
Recalling firm: Zimmer GmbH
Product: Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical instrument.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: The three-point array may break during use, resulting in surgical delay and an increased risk of infection.
Root cause tag: design
FDA root cause: Device Design
Action: Consignee was notified by phone and email on or about 4/27/06. Contact Zimmer Inc. at 1-574-267-6131 for assistance.
Quantity in commerce: 239
Distribution: Nationwide
Product codes and lots: Lots: PC040050, PC030403, PC040292, PC040293, PC050034, PC050129 and PC050034-1.

Product code HAW

K041369Class IINavitrack System - S&n Image Free Hip, Model Pro-03017Orthosoft, Inc. / cleared 2004-06-22

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)