Z-0688-2017Class III

Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF...

Name: Z-0688-2017 Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF...
Creator: MicroPort Orthopedics Inc.
Published: 2016-06-21
License: https://open.fda.gov/license/

Microport Orthopedics Inc. / initiated 2016-06-21 / Terminated / root cause: design

FDA source

MicroPort Orthopedics Inc. began a recall of Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF... on 2016-06-21. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0688-2017
Classification: Class III
Status: Terminated
Initiated: 2016-06-21
Posted: 2016-12-01
Terminated: 2017-07-01
Recalling firm: Microport Orthopedics Inc.
Product: Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF 38BF5460SP, REF 38BF5662, REF 38BF5662SP, REF 38BF5864, REF 38BF5864SP, REF 38BF6066, REF 38BF6066SP, REF 38QH3644, REF 38QH3846, REF 38QH4048, REF 38QH4250, REF 38QH4452, REF 38QH4654, REF 38QH4856, REF 38QH5058, REF 38QH5260, REF 38QH5462, REF 38QH5664, REF 38QH5666, REF 38SC3650, REF 38SC3852, REF 38SC4054, REF 38SC4256, REF 38SC4458, REF 38SC4660, REF 38SC4862, REF 38SC5064, REF 38SC5266, REF 38SC5468, REF 38SC5670, REF 38SC5672 For use with the conserve metal head
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected]. For questions regarding this recall call 901-867-4771.
Quantity in commerce: 68,221 units
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.
Product codes and lots: REF 38BF3642 Serial Numbers: 1380112, 1399025, 1402166, 1340677, 1427276, 1429743 REF 38BF3642SP Serial Number 1416590 REF 38BF3844 Serial Numbers: 1368260, 1402167, 1399026, 1380113, 1418795 REF 38BF3844SP Serial Number 1416814 REF 38BF4046 Serial Numbers: 1368261, 1380114, 1402168, 1399027, 1418796, 1429744, 1449113 REF 38BF4046SP Serial Number 1416950 REF 38BF4248 Serial Numbers: 1397139, 1368262, 1381417, 1399029, 1422026, 1418797, 1433514, 1449114, 1452995 REF 38BF4248SP Serial Number 1416816 REF 38BF4450 Serial Numbers: 1380115, 1399031, 1399231, 1373711, 1366654, 1418948, 1433515, 1431187, 1449115, 1482461, 1484998 REF 38BF4450SP Serial number 1416563 REF 38BF4652 Serial Numbers: 1380116, 1395709, 1368263, 1373712, 1399233, 1427277, 1429745, 1433516, 1445264, 1449116, 1460186, 1460187, 1482463, 1481980 REF 38BF4652SP Serial Numbers: 1417403, 1417616 REF 38BF4854 Serial Numbers: 1381418, 1399234, 1373904, 1368264, 1399235, 1427278, 1431188, 1433517, 1445265, 1460189, 1460188, 1468891, 1481979, 1484999 REF 38BF5056 Serial Numbers: 1381419, 1399236, 1373905, 1368265, 1397140, 1402169, 1413708, 1427279, 1445266, 1449117, 1452997, 1468892, 1468893, 1476014, 1476013, 1482462, 1571773, 1571772, 1650637, 1650638, 1651368 REF 38BF5258 Serial Numbers: 1397141, 1399237, 1368266, 1380117, 1422025, 1431189, 1445267, 1449118, 1452996, 1468894, 1476016, 1482460, 1481456, 1571771, 1571770, 1589362, 1650639 REF 38BF5258SP Serial numbers: 1416945 REF 38BF5460 Serial Numbers: 1368267, 1380118, 1397142, 1399238, 1402170, 1429746, 1433518, 14335181454410, 14335181454409, 1452478, 1476017, 1481978, 1484997, 1651370 REF 38BF5460SP Serial Number 1416944 REF 38BF5662 Serial Numbers: 1368268, 1381420, 1399239, 1422021, 1431190, 1452994, 1484996 REF 38BF5662SP Serial Number 1416957 REF 38BF5864 Serial Numbers: 1368269, 1402171, 1380124, 1399240 REF 38BF5864SP Serial Number 1416589 REF 38BF6066 Serial Numbers: 1399241, 1402172, 1380125, 1427280 REF 38BF6066SP Serial Number 1416815 REF 38QH3644 Serial Numbers: 098450454, 098450453 REF 38QH3846 Serial Numbers: 087448320, 087448319, 028455786, 108636368, 039752495, 089843391, 1283757 REF 38QH4048 Serial Numbers: 087448317, 087448318, 078573304, 108636369, 039753686 REF 38QH4250 Serial Numbers: 087447402, 087447838, 038474921, 088573305, 019741984, 039783429 REF 38QH4452 Serial Numbers: 087446899, 087447160, 058552436, 029746761, 069832435 REF 38QH4654 Serial Numbers: 036310979, 036312725, 066322950, 087445485, 087445891, 058533122, 088584084, 029751144, 059832434, 099864589,109864590 REF 38QH4856 Serial Numbers: 036308619, 036312726, 066322951, 087443056, 087444883, 038510025, 058552900, 128691657, 039763773 REF 38QH5058 Serial Numbers: 036303438, 036310069, 066322952, 087424788, 087444884, 038515854, 088584085, 029746762, 059832436, 059832438, 1322641 REF 38QH5260 Serial Numbers: 036310978, 036312727, 087445887, 087446423, 088552437, 128688680, 059831040 REF 38QH5462 Serial Numbers: 036311691, 066322954, 087445888, 087446426, 028469801, 058552901, 128691658, 029763769, 059838299 REF 38QH5664 Serial Numbers: 087446896, 087447161, 058544859, 118691659, 029751973, 059829624 REF 38QH5666 Serial Numbers: 087447403, 087447839, 058544860, 128691660, 059830306 REF 38SC3650 Serial Numbers: 025149290, 025160237, 025174327, 075208859, 085242413, 085246262, 105249039, 016300068, 026305920, 096368471, 126385423, 027393904, 087458988, 068573306, 108602432, 029744514 REF 38SC3852 Serial Numbers: 025149144, 025170078, 025160238, 035179216, 075232801, 075242414, 085246264, 105267353, 115277853, 026301520, 026317024, 036319642, 056329110, 106333747, 027385922, 107460700, 107465345, 118703700 REF 38SC4054 Serial Numbers: 025149111, 025160239, 035179223, 075236081, 085242415, 085246267, 115276025, 016277854, 036318111, 036318361, 066320283, 097438943, 127465344, 108566756, 029753065 REF 38SC4256 Serial Numbers: 025149838, 025146436, 025179217, 035188989, 075233865, 085242416, 095257911, 105268093, 105269854, 125277855, 125283868, 036318819, 066320284, 106368472, 097460701, 097480974, 038466319, 019746760 REF 38SC4458 Serial Numbers: 025144180, 025146460, 035179222, 035188990, 075233866, 085242417, 085249038, 105269855, 115276026, 115283869, 026305908, 056320285, 106336785, 027385923, 077437212, 107460702, 107461472, 029566757 REF 38SC4660 Serial Numbers: 025142838, 025146459, 025174328, 035188992, 035179221, 075233867, 085242418, 095262956, 105269857, 016283870, 036319135, 046320286, 066341722, 106368473, 116371016, 037389856, 037387396, 077432335, 107465343, 108492001, 019745503 REF 38SC4862 Serial Numbers: 025144201, 025140464, 025190407, 025170075, 025170076, 075233868, 085242419, 105262954, 105269861, 016283871, 036319136, 066320287, 087459243, 108605237, 029745502 REF 38SC5064 Serial Numbers: 025128517, 025150758, 025160240, 025170072, 025170074, 035188993, 035190419, 085242420, 085248657, 105263392, 105269867, 016283872, 066320288, 077438092, 068493738, 108605238 REF 38SC5266 Serial numbers: 025190387, 025128518, 025160241, 035179218, 035188994, 035192254, 085242421, 085248658, 105269869, 036319137, 027389086, 087438091, 107465342 REF 38SC5468 Serial Numbers: 025190390, 025128519, 025160242, 025174329, 025187586, 035190750, 075188995, 075192255, 085242394, 095248659, 105274072, 106331324, 077436606, 018495671 REF 38SC5670 Serial Numbers: 025179948, 025190082, 025179949, 025128520, 025155250, 025160243, 035179219, 085242422, 085248660, 105269872, 116331326, 107460703 REF 38SC5672 Serial Numbers: 025190391, 025190397, 025190398, 025155817, 025158548, 025160244, 035188996, 035179220, 075204364, 085242423, 095248661, 026302015, 027394748, 107460704, 028486699

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0688-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0683-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0684-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0685-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0686-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0687-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0688-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01
Z-0689-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-07	2016-12-01

Product code LZO

K100866Class IIProfemur Hip System Modular NecksWrightmedicaltechnologyinc / cleared 2010-04-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)