—#72807

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K041369
Affected lot / code info: Lots: PC040050, PC030403, PC040292, PC040293, PC050034, PC050129 and PC050034-1.

Why it was recalled

The three-point array may break during use, resulting in surgical delay and an increased risk of infection.

Root cause (FDA determination)

Device Design

Action the firm took

Consignee was notified by phone and email on or about 4/27/06. Contact Zimmer Inc. at 1-574-267-6131 for assistance.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2006-04-27
Posted by FDA: 2008-09-23
Terminated: 2009-03-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.