Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head
- Company
- Microport Orthopedics Inc.
- Recall Initiated
- June 21, 2016
- Posted
- December 1, 2016
- Terminated
- July 1, 2017
- Recall Number
- Z-0683-2017
- Quantity
- 5,009 units
- Firm Location
- Arlington, TN
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.
Distribution
Worldwide 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.
Lot / Code Info
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
Root Cause
Device Design
Action Taken
MicroPort 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.