Class 2 Device Recall Detachable THandle

• Date Initiated by Firm: October 21, 2005
• Date Posted: December 28, 2005
• Recall Status: Terminated on April 16, 2008
• Recall Number: Z-0328-06
• Recall Event ID: 33988
• Product Classification: Orthopedic Manual Surgical Instrument - Product Code LXH
• Product: Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G
• Code Information: Revision G (instrument not tracked by lot number).
• FEI Number: 1000116912
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758
• Manufacturer Reason for Recall: Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.
• FDA Determined Cause: Other
• Action: The firm initiated the recall on 10/21/05 via letter to all consignees.
• Quantity in Commerce: 141 units.
• Distribution: Device distributed nationwide to direct accounts in AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, MO, MT, NM, NH, NJ, OK, OH, PA, SC, SD, TX, UT, VA, and WA. Foreign distribution to Saudi Arabia, Japan and Germany.
• 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.