Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical inst
FDA device recall Z-2445-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection.
- Action taken
- Firm's sales representatives were notified via e-mail on 8/6/07 to review their inventory and that of their accounts and to notify the firm of their location so that they could be replaced. Contact the firm by telephone at 574-267-6131 for additional information concerning this recall.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 39
- Distribution
- Nationwide Distribution including states of California, Florida and Washington.
- Date initiated
- 2007-08-06
- Date posted
- 2008-09-20
- Date terminated
- 2009-03-11
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 (K030827) | Orthosoft, Inc. | 2003-05-23 |