Recall Z-2444-2008 ยท HAW Neurological Stereotaxic Instrument
Zimmer Inc.
Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical instrument.
| Date | Sep 23, 2008 (initiated Apr 27, 2006) |
| Status | Terminated |
| Reason | The three-point array may break during use, resulting in surgical delay and an increased risk of infection. |
| 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 | 239 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041369 | NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 Orthosoft, Inc., Jun 22, 2004 |