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 Recall Z-2444-2008 · Posted 2008-09-23
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2006-04-27
Date Terminated2009-03-11
Product Quantity239
Reason for Recall
The three-point array may break during use, resulting in surgical delay and an increased risk of infection.
Firm Action
Consignee was notified by phone and email on or about 4/27/06. Contact Zimmer Inc. at 1-574-267-6131 for assistance.
Root Cause
Device Design
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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