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U.S. Department of Health and Human Services

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

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 Class 2 Recall
PROTHESE A EXPANSION COMPLETE D6 LG 12 MM
see related information
Date Posted October 31, 2012
Recall Status1 Terminated on January 07, 2014
Recall Number Z-0185-2013
Recall Event ID 63338
Premarket Notification
510(K) Numbers
K003016  K012091  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, Tennessee 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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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