Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN
FDA device recall Z-2444-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The three-point array may break during use, resulting in surgical delay and an increased risk of infection.
- Action taken
- 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
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 239
- Distribution
- Nationwide
- Date initiated
- 2006-04-27
- Date posted
- 2008-09-23
- Date terminated
- 2009-03-11
- Location
- Warsaw, IN
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Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 (K041369) | Orthosoft, Inc. | 2004-06-22 |