Recall Z-2445-2008 ยท HAW Neurological Stereotaxic Instrument
Zimmer Inc.
Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.
| Date | Sep 20, 2008 (initiated Aug 6, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 39 |
| Distribution | Nationwide Distribution including states of California, Florida and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030827 | NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204 Orthosoft, Inc., May 23, 2003 |