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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 17, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 01, 2004
Recall Number Z-0718-04
Recall Event ID 26157
Product Classification Reamer - Product Code HTO
Product Apex Pilot Shaft 17.5mm
Code Information Catalog Number: 690117 Lot NUmbers: 052, 113, 214
Recalling Firm/
Manufacturer		 Apex Surgical, LLC
12 Harding Street, Suite 202
Lakeville MA 02347
For Additional Information Contact Edward J. Cheal, Ph.D
508-947-6500
Manufacturer Reason
for Recall		 Pilot shaft may break during reaming or broaching of the femur
FDA Determined
Cause 2		 Other
Action Apex Surgical notified accounts by letter on 1/17/03, advising users to discontinue use of the stem pilots and return the pilots, and associated broaches and reamers because they would not be interchangeable with the new design.
Quantity in Commerce 45 units
Distribution CT, OH, FL, OK, TX, RI, NV, SC,
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.
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