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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 Device Recall Trilogy Acetabular AB Shells with Cluster Holes see related information
Date Posted February 04, 2013
Recall Status1 Terminated on June 20, 2014
Recall Number Z-0774-2013
Recall Event ID 63531
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 IN 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
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 Original Applicant = ZIMMER, INC.
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