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U.S. Department of Health and Human Services

Class 3 Device Recall Lineage Liners

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 Class 3 Device Recall Lineage Linerssee related information
Date Initiated by FirmJune 21, 2016
Date PostedDecember 01, 2016
Recall Status1 Terminated 3 on July 01, 2017
Recall NumberZ-0683-2017
Recall Event ID 75063
510(K)NumberK100866 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductLineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head
Code Information REF 70102846 Serial numbers: 06217334, 06217335, 06217336, 07218879, 10229555, 12339970, 12342378, 09345262, 11356669, 03459689, 03460757, 05478476, 06487845, 09491060, 11497839, 114131987, 025179937, 035198678, 035199154, 075211008, 085258159, 095267627, 085267672, 125294335,  016302354, 026317823, 026322014, 056332874, 056340972, 066346343, 066347890, 066349011, 076361472, 086364785, 086365941, 086365942, 086366614, 027403696, 027405367, 037417244, 037417245, 037423200, 047423201, 057426382, 057436510, 067442040, 067445874, 067447459,  077449134, 077456252, 077456253, 077458343, 087458991, 097465277, 097465278, 107473197, 097476410, 107481165, 107485823, 107486701, 117486702, 117495033, 127500338, 127500339, 038523902, 028523903, 028533974, 028533976, 038533977, 048571510, 048571511, 078595472,  078595473, 108669048, 108694963, 108694964, 118706230, 029763680, 029780243, 069816370, 069829627, 069835276, 069840533, 069841537, 069842578, 069871618, 099893231, 0301059446, 0301059448, 0301059449, 0301076824, 0301080515, 0301084486, 0301084488, 0301085776, 0301089607, 0301089608, 0401112808, 0601145034, 0601146232, 0801172562, 0801172985, 1101217377, 1381687, 1382260   REF 70202852 Serial Numbers: 06217338, 03442273, 03457113, 094103603, 114115155, 114131988, 067444763, 097458085, 117501995, 018507062, 078595474, 022A147720  REF 70202852 Serial Numbers: 022A147721, 022A147722, 022A147723, 022A147723, 022A147724, 06217340, 04217341, 04217342, 04217343, 04218880, 05218881, 04218882, 08225650, 08227481, 08227482, 10228744, 11228846, 03334611, 05335140, 03339967, 03339968, 08342274, 09345234, 08345235,  10349867, 10349868, 10349869, 03455651, 03457114, 03460758, 05478475, 06487846, 08491061, 08497840, 08499658, 094103604, 114115156, 114131989, 015140898, 015145854, 015167730, 025182498, 025182499, 025185569, 035198684, 055208762, 055228595, 055229916, 065242431,  075242432, 065245652, 085258160, 095267361, 095267673, 085267674, 105281165, 115291529, 125292876, 115292878, 016311871, 016311871, 016311872, 026316752, 026317146, 026317824, 026319568, 046326036, 046329102, 056331319, 056342436, 056344951, 066346344, 066349010,  076361473, 086364783, 086365943, 106369766, 116371021, 116373886, 116382786, 037399873, 027403168, 027403697, 027405368, 027408532, 027408593, 027408594, 027409933, 037417800, 037420888, 047423580, 057431859, 057436511, 067444764, 067445875, 067447445, 067447455,  077449135, 077452390, 077453351, 077457329, 097458992, 087459274, 087464167, 087464168, 097464169, 087466761, 087466762, 087466763, 097471664, 107476411, 107481166, 107481167, 107481168, 107488772, 107488773, 117488774, 117500335, 117500336, 127500337, 018507065,  028507066, 028533978, 028533979, 038533980, 038533981, 068571512, 068571513, 068595475, 068595477, 068628972, 078657275, 078657276, 088657277, 088657277, 088666909, 088668637, 088681722, 098688681, 098688682, 108694972, 108694973, 108694974, 108706231, 019744517,  029744518, 029752395, 029752396, 019780244, 069805762, 059805763, 049826202, 039826203, 059832457, 069837384, 059840534, 069841535, 069841536, 069843282, 079843284, 079871619, 099893232, 099894028, 109943611, 109949751, 119976454, 129984899, 0101009599, 0101019757,  0101048257, 0201049093, 0301049096, 0301064289, 0301064290, 0301076825, 0401079670, 0401079671, 0401089609, 0401089610, 0401108733, 0401109165, 0501137724, 0601138315, 0601138736, 0601142035, 0801177943, 0801178058, 0701179671, 0801189482, 0801189732, 1101214882, 1001214883, 1101215441, 0511308183, 0511308908, 0511311535, 1379458, 1379459, 1379605, 1381323, 1384695   REF 70302858 Serial Numbers: 04217339, 10228742, 09491063, 056340187, 106369767, 106373887   REF 70303258 Serial Numbers: 022A147725, 022A147726, 022A147727, 022A147739, 04217344, 04217345, 04217346, 08225648, 08225648, 08227483, 10228741, 10230588, 05335139, 11339972, 03449870, 03460759, 05478477, 06487847, 08491062, 08497841, 114131990, 114131991, 015155783, LLALMD033E, 075208766, 085258161, 125294334, 016308023, 056333740, 066347206, 086364784, 116366898, 116382787, 037417544, 047420889, 057431860, 057436512, 067445876, 067447458, 077451556, 097458361, 097475906, 107481169, 117481170, 107489026, 127500332, 117500333, 127500334, 018507067, 028533983, 098625460, 108716003, 029753067, 079828958, 069843288, 0201044697, 0401085943, 0401092474, 0401092475, 0401106375, 0401107035, 0501132274, 0601143641, 0601151739, 0701165736, 0901197191, 1388534   REF 70402864 Serial numbers: 11228743, 056339647, 066347891  REF 70403264 Serial numbers: 08228131, 056330591  REF 70403664 Serial Numbers: 062A147184, 062A147738, 06217348, 09339971, 11355652, 03457115, 03460761, 05478478, 015140899, 055199111, 075241210, 016303424 
Recalling Firm/
Manufacturer		 MicroPort Orthopedics Inc.
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information ContactRachael Wise
901-867-4771
Manufacturer Reason
for Recall		Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
FDA Determined
Cause 2		Device Design
ActionMicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers notifying them of the change in the instructions for use on July 7th, 2016 by email. The firm also notified US hospitals where the implantation surgeries occurred within the last twelve (12) months by letter on July 13th, 2016 delivered by FedEx Priority. Customers were asked to complete and return the enclosed form even if they do not have any affected product to return by fax to 1-901-451-6032 or PostMarket@ortho.microport.com. For questions regarding this recall call 901-867-4771.
Quantity in Commerce5,009 units
DistributionWorldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LZO
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