—#72809

Product

Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K030827
Affected lot / code info: Lots 050433, BP050199, BP050258 and BP050350.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide Distribution including states of California, Florida and Washington.

Timeline

Recall initiated: 2007-08-06
Posted by FDA: 2008-09-20
Terminated: 2009-03-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.