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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- MicroPort Orthopedics Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0683-2017
Related Recalls
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
MicroPort Orthopedics
Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
MicroPort Orthopedics
One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
MicroPort Orthopedics
One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.