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U.S. Department of Health and Human Services

Class 2 Device Recall Universal Optical Tracker Fixation

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  Class 2 Device Recall Universal Optical Tracker Fixation see related information
Date Initiated by Firm August 06, 2007
Date Posted September 20, 2008
Recall Status1 Terminated 3 on March 11, 2009
Recall Number Z-2445-2008
Recall Event ID 49122
510(K)Number K030827  
Product Classification Stereotaxic instrument - Product Code HAW
Product Universal Optical Tracker Fixation, not sterile, Manufactured by Orthosoft, Montreal, Canada, REF 111.031. Surgical instrument.
Code Information Lots 050433, BP050199, BP050258 and BP050350.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
574-267-6131
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 39
Distribution Nationwide Distribution including states of California, Florida and Washington.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = ORTHOSOFT, INC.
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