Class 2 Device Recall PROTHESE A EXPANSION COMPLETE D6 LG 12 MM

• Date Initiated by Firm: September 05, 2012
• Date Posted: October 31, 2012
• Recall Status: Terminated on January 07, 2014
• Recall Number: Z-0185-2013
• Recall Event ID: 63338
• 510(K)Number: K003016 K021346 K043073 K052915 K092201 K111698
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005 Orthopaedic
• Code Information: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005
• Recalling Firm/ Manufacturer: Wright Medical Technology Inc; 5677 Airline Rd; Arlington TN 38002-9501
• For Additional Information Contact: Doug Shufelt ; 901-867-4655
• Manufacturer Reason for Recall: There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
• FDA Determined Cause: Packaging process control
• Action: Wright sent an Urgent Product Recall Notification letter dated September 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and immediately return to Wright Medical Technology, Inc. Customers were asked to complete and return the enclosed notification form by fax to 901-867-7401. For questions customers should call 901-867-4324. For questions regarding this recall call 901-867-4655.
• Quantity in Commerce: 840 units
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, The Netherlands, Argentina, Brazil, Chile, China, Japan, Taiwan, Turkey, United Arab Emirates, Australia, South Africa, Russia, and United Kingdom.
• 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 = LPH