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U.S. Department of Health and Human Services

Class 2 Device Recall Trilogy Acetabular Shell Spiked

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 Class 2 Recall
Trilogy Acetabular Shell Spiked
see related information
Date Posted February 04, 2013
Recall Status1 Terminated on June 20, 2014
Recall Number Z-0772-2013
Recall Event ID 63531
Premarket Notification
510(K) Numbers
K934765  K980711 
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
Product Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Code Information 00369642 00369648 00370032 00369656 61642334 00369644 61832805 61817455 61269936 61412631 61630564 00369407 61642337 61324694 61630563 61269937 61825837 61548181 61846490 61941029 61952408 61329095 61421263 61548182 61642336 60983133 61237717 61421264 00369660 61734272 62001310 61873606 61548185 61237808 61548184 61642338 60919315 61421260 61955590 61548186 61825841 61215919 61321081 61846488 61421258 61762005 61469142 61803767 61212922 61324695 61630550 61269940 61269941 61431735 61469143 61548190 61642339 61630567 61246475 61548191 61630565 61269943 61734270 60983134 61803771 61235835 61324696 61235836 61955591 61321084 61517446 61842609 61869695 00369695 61469149 61215920 61642341 61630551 61548201 61809017 61421267 61548199 61251222 61421266 61783461 61803769 61947736 61952415 61199836 61199839 61283453 61283454 61921683 00369661 61469151 61548205 61952422 61630552 61809012 61642342 61548206 61237809 61923871 61925091 61783462 61403530 61283455 61191067 00370048 00369663 61469152 61215929 61548212 61630569 61923872 61630553 00369638 61469154 00369651 00370752 61975586 00369664 11001720 61490760 62023765 61742082 61222252 61271664 61511137 61629985 61667049 61769838 61844002 61955479 61979981 61227814 61676615 61236278 61549718 61721127 61550409 62159365 61714399 11002260 62052850 07892033 61843998 61384952 61442061 61499614 61532992 61629982 61667062 61754419 61980115 61549720 61461917 61784734 62054500 61511139 61676596 61742071 61857680 61962840 62136223 61203311 62126090 61384953 61979983 07892046 61416489 61737672 61354833 61330560 61456504 62023767 61442060 61354834 07892052 61375761 61450049 62030472 61531423 61581705
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
For Additional Information Contact Jaime L. Weeks
574-372-4807
Manufacturer Reason
for Recall
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.
Quantity in Commerce 275,952 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.
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 = ZIMMER, INC.
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