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U.S. Department of Health and Human Services

Class 2 Device Recall Trilogy Acetabular AB Shells with Cluster Holes

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 Class 2 Recall
Trilogy Acetabular AB Shells with Cluster Holes
see related information
Date Posted February 04, 2013
Recall Status1 Open
Recall Number Z-0774-2013
Recall Event ID 63531
Premarket Approval
PMA Number
P040048
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented - Product Code MRA
Product Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Code Information Lot 61824006 61804625 61863921 61940938 61770118 61770119 61847292 62036280 62041700 62041701 62074562 61676075 61686843 61878991 62086541 07891486 61771223 61236214 61684940 61576456 61771214 61514324 62049465 61398128 61543099 61720987 61738788 61838669 61851627 61531431 61532988 61559753 61610337 61633328 61639533 61667050 61680958 61714507 61737663 61761440 61765336 61765339 61771213 61771215 61800650 61807684 61810992 61821391 61831558 61844005 61946147 61980002 61992760 62005870 62011425 62016937 62073253 62084392 61676078 61962791 62036281 61338624 61581713 61817237 61581712 61581714 61656292 61757712 61765340 61821393 61236215 61236216 61338666 61398129 61514325 61514326 61532990 61581711 61727955 61738789 61771216 61771221 61784813 61796131 61831565 61838671 61844006 61851628 61946319 61992761 61810993 61930116 62036282 61610338 61639534 61962792 61998856 62011426 61684942 61667051 62078581 61676591 61476225 61639535 62049467 61543101 61771224 61553782 61734089 62052856 61980006 61236218 61236219 61765337 61831549 62078789 61236217 61531433 61581715 61629973 61656293 61727956 61752676 61771217 61771218 61780740 61791906 61807685 61817238 61831566 61838672 61844007 61860174 62011427 62023771 62073255 61998857 61667052 61676081 61962793 61676592 61338667 61476226 61236220 61236223 61757711 61791907 61709237 61771219 61236224 61236222 61236225 61499616 61532989 61566825 61576457 61639536 61670754 61720991 61742089 61765341 61796132 61801296 61851630 61980010 61236221 61375787 61531434 61531435 61549723 61553783 61629974 61633329 61656294 61714520 61761441 61771220 61771225 61817239 61821392 61831602 61844008 61860172 62023772 61734088 61381468 61771222 61807695 62078790 61271672 61962794 61450095 61935498 62011428 61648309 61831560 61992762 61676593 61684943 61589940 61398130 62073158 62049468 62078791 61236226 61566826 61676594 62052858 61796133 61816923 61926630 61585972 61639537 61761437 61780739 61946148 61227823 61236227 61236228 61658812 61684944 61720985 61801295 61831554 61838670 61860173 61962795 61338627 62011408 61615428 61844009 62016940 61236229 61566827 61765338 61734090 61817240 61639538 61615429 61676614 61796134 77000185 77000183 61984086 61824007 61686847 77000184 07891300 61566829 61254413 61254414 61217880 62084422 61217883 61217882 61254415 62042220 61217884 61254416 61281004 61450096 61992779 61689279 61784742 61962845 61603391 61633330 61656295 61819023 61278095 61553784 61566830 61946162 61254417 62073243 61278096 61217885 61254418 61254419
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.
PMA Database PMAs with Product Code = MRA and Applicant = ZIMMER, INC.
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