Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.
FDA Recall Z-2445-2008 · Posted 2008-09-20
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2007-08-06
Date Terminated2009-03-11
Product Quantity39
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution including states of California, Florida and Washington.
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.