More About Zimmer Knee Devices

Zimmer Knee Recall

As the biggest manufacturer of joint replacement devices, Zimmer has faced a number of problems over the years that have led to recalls of its knee replacement devices in particular. Since merging with Biomet in 2015, the company’s troubles have continued, as additional recalls have been issued for various knee and other joint replacement medical devices.

Many of the Zimmer knee lawsuits have been filed against Zimmer Biomet as a result.

Zimmer NexGen Recalls

Zimmer’s NexGen Knee Replacement Systems products are at the heart of the company’s recalls, with the NexGen Flex, particularly the tibial components, causing the most problems. The U.S. Food and Drug Administration (FDA) approved the NexGen Flex through a 510(k) submission, meaning that the device is simply a modification of a previous FDA-approved device and is just as safe and effective. As a result, the device did not undergo clinical trials before going to market.

Not long after receiving NexGen implants, some patients began to experience negative side effects. Many required revision surgery to replace their implants after as little as two years. Knee replacements typically last for up to 15 years.

Learning of these complications, Zimmer sent a device correction letter to surgeons addressing the implantation of their devices. The letter stated that the device may loosen if threaded incorrectly, and provided new instructions for successful implantation. The company did not allude to any issues with the device itself. In total, 114 patients filed Medical Device Reportings (MDRs) with the FDA complaining of loosening in the implant device that required revision surgery.

In September 2010, the FDA issued a Class 2 Recall for over 68,000 NexGen MIS Tibial Components. By that point, thousands of patients had received the implant.

Persona Trabecular Metal Tibial Plate Recall

On January 28, 2015, Zimmer initiated a voluntary recall of its Persona Trabecular Metal Tibial Plate, a component of the company’s Persona-branded knee replacement devices. According to the recall notice, Zimmer had received an increase in complaints that the tibial plates were coming loose and forming “radiolucent lines” – that is, linear spaces between the device and the joint cement holding it in place.

More than 11,600 knee replacement devices were affected by this recall. Zimmer instructed hospitals, orthopedic surgeons, and distributors to return the defective devices. It is unclear from the recall notice how many people may have already had the malfunctioning devices surgically implanted.

Other Zimmer Knee Device Recalls

Zimmer has issued a number of other recalls on parts related to its knee replacement devices. Many of these recalls were instituted before any of the knee replacement components could be surgically implanted into patients. However, there is still the risk that some of the components were not returned by the distributors, hospitals, or doctors to whom they were sent, and it is possible some of them may have been used in arthroplasty operations.

In 2010, Zimmer recalled the MIS Tibial Component after the company received reports about improperly locking screws and stems on the device. Over 100 people filed complaints to the FDA that the device was coming loose, which led to the need for knee revision surgery.

Sulzer Medica, a company acquired by Zimmer in 2003, paid $1 billion in 2002 to settle thousands of lawsuits filed by customers who received joint implants in their knees and hips. As it turned out, the manufacturing process for the company’s Natural Knee II Tibial Baseplate implant had left an oily substance on the device, which caused problems for patients up to a year later.

If you have more questions, feel free to contact us here, and we’ll do our best to help you.

The table below provides a summary of other recalls that Zimmer has conducted over the last several years.

Additional ResourceList of Zimmer Knee Device Recalls
Expand Resource
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left
Recall Date: March 17, 2016 (unknown number of units)

Lot Numbers: 62646580

NexGen Knee System Components
Recall Date: January 11, 2016 (88,389 units)

Lot Numbers: 1990109, 61990189, 61990190, 61990191, 61990921, 61990922, 61990923, 61990924, 61990925, 61990927, 61990928, 61991296, 61991297, 61991298, 61991300, 61991301, 61992060, 61992061, 61992062, 61992542, 61992543, 61992544, 61992545, 61992983, 61993211, 61993212, 61993213, 61993214, 61993935, 61993939, 61993943, 61994196, 61994199, 61994201, 61994202, 61994203, 61994204, 61994205, 61994206, 61994207, 61994208, 61994209, 61994210, 61994211, 61994212, 61994213, 61994214, 61994836, 61994837, 61994841, 61994842, 61994844, 61996362, 61996363, 61996793, 61996795, 61996796, 61996797, 61996798, 61996799, 61996876, 61996957, 61996958, 61997347, 61997525, 61997526, 61997527, 61997528, 61997529, 61997530, 61998645, 61998647, 61998649, 61998945, 61998946, 61998947, 61998948, 61998949, 61998951, 61999727, 61999728, 61999729, 61999730, 61999731, 61999732, 62000731, 62000732, 62000733, 62000734, 62000735, 62000736, 62000737, 62000738, 62000739, 62000740, 62000741, 62000742, 62000743, 62000744, 62000745, 62000746, 62001107, 62001108, 62001109, 62001110, 62001111, 62001112, 62001113, 62002148, 62002149, 62002385, 62002388, 62002389, 62002392, 62002393, 62003830, 62003831, 62003832, 62003833, 62005361, 62005364, 62005365, 62005366, 62005367, 62005368, 62005457, 62005458, 62005459, 62005460, 62005461, 62005462, 62005463, 62005464, 62005465, 62005466, 62005467, 62005468, 62005469, 62005470, 62005471, 62005472, 62005718, 62006096, 62006097, 62006098, 62006099, 62007661, 62007663, 62007664, 62007665, 62007666, 62007667, 62007668, 62007669, 62008303, 62008304, 62008305, 62008306, 62008307, 62008308, 62008309, 62009666, 62009667, 62009668, 62009670, 62009672, 62009673, 62010930, 62010931, 62010932, 62010933, 62010934, 62010935, 62011839, 62011840, 62011841, 62011842, 62011843, 62011844, 62011846, 62012293, 62012294, 62012295, 62012296, 62012297, 62012298, 62012299, 62012300, 62012301, 62012302, 62012303, 62013157, 62013159, 62013161, 62013163, 62013164, 62013166, 62014192, 62014193, 62014194, 62014195, 62014196, 62016167, 62016169, 62016170, 62016171, 62016173, 62016488, 62016489, 62016490, 62016491, 62016809, 62017267, 62017617, 62017618, 62017620, 62017621, 62017622, 62017630, 62017631, 62018148, 62018149, 62018415, 62018417, 62018418, 62018420, 62018421, 62019092, 62019094, 62019095, 62019096, 62019097, 62019099, 62019100, 62019101, 62019102, 62019103, 62019104, 62019105, 62019106, 62019118, 62019119, 62019375, 62019376, 62019377, 62019499, 62019500, 62019502, 62019749, 62019750, 62019751, 62019752, 62019753, 62019754, 62019755, 62019756, 62019757, 62020212, 62020810, 62020811, 62020812, 62020813, 62020817, 62020818, 62021089, 62021090, 62021091, 62021092, 62021093, 62022047, 62022329, 62022330, 62022887, 62022888, 62022889, 62022890, 62022891, 62022892, 62022893, 62022894, 62022895, 62022896, 62023293, 62024167, 62024168, 62025165, 62025166, 62025167, 62025168, 62025169, 62025170, 62025171, 62025172, 62025173, 62025174, 62025175, 62025195, 62025378, 62025379, 62025529, 62025530, 62025531, 62025532, 62025533, 62025534, 62025535, 62026364, 62026365, 62026367, 62026912, 62026913, 62027201, 62027202, 62027203, 62027204, 62027206, 62027207, 62027402, 62027403, 62027404, 62027405, 62027406, 62027407, 62027408, 62027409, 62028451, 62028452, 62028453, 62028454, 62028654, 62028655, 62028656, 62028657, 62028658, 62028659, 62028660, 62029526, 62029527, 62029865, 62029866, 62029867, 62029868, 62029995, 62029996, 62029998, 62030002, 62030003, 62030005, 62030006, 62030008, 62030009, 62030011, 62030012, 62030013, 62030015, 62030404, 62030405, 62030420, 62030422, 62030423, 62030425, 62030601, 62030602, 62030603, 62030604, 62030607, 62030608, 62030637, 62030639, 62030640, 62030823, 62030825, 62030826, 62030827, 62030828, 62030830, 62030833, 62030882, 62030883, 62030884, 62031819, 62031820, 62031821, 62031822, 62031823, 62031824, 62031825, 62031826, 62031827, 62031828, 62031829, 62031830, 62031842, 62031843, 62031844, 62032089, 62032224, 62032227, 62032228, 62032229

NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat
Recall Date: December 3, 2015 (384 units)

Lot Numbers: 62491580 (P/N 00598003701) and 62460315 (P/N 00598603701)

PRI Femoral Impactor Block
Recall Date: April 30, 2015 (1,689 units)

Lot Numbers: 56572845, 56574197, 56574534, 56574775, 56575838, 56573249, 56574198, 56574535, 56575827, 56575839, 56573282, 56574325, 56574536, 56575828, 56575840, 56573283, 56574326, 56574604, 56575829, 56576089, 56573284, 56574327, 56574605, 56575830, 56576090, 56573285, 56574328, 56574606, 56575831, 56576091, 56574130, 56574329, 56574607, 56575832, 56576421, 56574135, 56574530, 56574608, 56575833, 56576429, 56574136, 56574531, 56574617, 56575836, 56576431, 56574137, 56574532, 56574714, 56575837, 56576544, 56574196, 56574533, 56574774

Persona Anterior Referencing Sizer with Locking Boom
Recall Date: March 10, 2015 (688 units)

Lot Numbers: Part # 42-5099-088-10; Lots: 56573342; 56574505; 56574999; 56574229; 56574818; 56575000; 56574230; 56574819; 56575020; 56574301; 56574820; 56575021; 56574349; 56574861; 56575072; 56574374; 56574862; 56575105; 56574375; 56574863; 56574504; 56574998

Zimmer PERSONA Tibial Articular Surface Inserter
Recall Date: November 25, 2014 (1,091 units)

Lot Numbers: 56572679; 56573170; 56574318; 56575056; 56572918; 56573378; 56574538; 56575057; 56572975; 56573379; 56574540; 56575058; 56572978; 56574123; 56574618; 56575059; 56572981; 56574124; 56574619; 56575060; 56572982; 56574223; 56574620; 56575061; 56573071; 56574291; 56574629; 56575062; 56573115; 56574292; 56574630; 56575065; 56573116; 56574316; 56574631; 56575080; 56573154; 56574317; 56575018

Persona Stemmed 5 Degree Cemented Tibia
Recall Date: October 9, 2014 (138 units)

Lot Numbers: Part Number 42-5320-079-02 Lot Number 62613813, Part Number 42-5320-071-02 Lot Number 62625781, Part Number 42-5320-075-01 Lot Number 62619031, Part Number 42-5320-075-01 Lot Number 62619040, Part Number 42-5320-079-01 Lot Number 62626696, Part Number 42-5320-071-01 Lot Number 62625790

Persona Tibial Articular Surface Inserter
Recall Date: October 7, 2014 (618 units)

Lot Numbers: 56572679; 56573170;, 56572918; 56573378;, 56572975; 56573379;, 56572978; 56574223;, 56572981; 56574291;, 56572982; 56574292;, 56573071; 56574316;, 56573115; 56574317;, 56573116; 56574318;, 56573154

Natural Knee II Revision Femoral Stem
Recall Date: October 2, 2014 (352 units)

Lot Numbers: 7884165, 7884736, 7884737, 7884738, 7890330, 11011448, 11012660, 60394169, 60415420, 60515793, 60564530, 60601129, 60614014, 60797044, 60803056, 60841848, 60922655, 60922656, 60927853, 60989112, 61017152, 61104192, 61135872, 61200531, 61284571, 61366919, 61464308, 61505310, 61533025, 61566733, 61742151, 61780361, 61784264, 61834192, 61834778, 61840307, 61930376, 61947884, 61947885, 62097910, 62146925, 62195165, 62249431, 62281270, 62305675, 62317987, 62358643, 62448678, 62536901, 62536902, 62536903, 62546527, 62560372, 62587577, 62610989, 62624715, 62624716, 62624717, 62624718, 62709664, 62709665, 62709667, 62709670

Recall Date: August 7, 2014 (77,737 units)

Lot Numbers: 62345370, 62402721, 62423922, 62424796, 62494665, 62563912, 62590524, 62696878, 62717331, 62347233, 62399612, 62428432, 62505575, 62563917, 62592279, 62692687, 62352330, 62416376, 62432157, 62490790, 62563913, 62590525, 62696881, 62357329, 62374803, 62412999, 62432797, 62490792, 62563911, 62654931, 62717334, 62357328, 62372411, 62407772, 62432794, 62463961, 62525489, 62563914, 62575756, 62702758, 62724743, 62358632, 62373739, 62405896, 62432154, 62463962, 62563916, 62656074, 62710626, 62432790, 62462267, 62572574, 62443455, 62456923, 62568289, 62357865, 62410790, 62423921, 62424804, 62500930, 62573363, 62695299, 62347240, 62399870, 62430403, 62504858, 62572571, 62692683, 62732165, 62357866, 62406970, 62432150, 62479624, 62573364, 62695293, 62351310, 62410788, 62435708, 62507548, 62569955, 62698727, 62358633, 62373740, 62410789, 62432796, 62465722, 62517280, 62581856, 62695873, 62363685, 62364505, 62407568, 62432152, 62463963, 62505999, 62572570, 62695889, 62710608, 62432792, 62499171, 62704629, 62445747, and 62497257

Zimmer PERSONA Distal Valgus Alignment Guide
Recall Date: July 30, 2014 (2,248 units)

Lot Numbers: 62313324, 62415340, 62561031, 62668655, 62313326, 62430425, 62580270, 62695918, 62341561, 62442314, 62590506, 62702686, 62358628, 62473246, 62594059, 62715932, 62368700, 62507846, 62611157, 62728374, 62376588, 62522771, 62624943, 62742362, 62396348, 62530133, 62637095, 62749057, 62401156, 62534170, 62641120, 62757397, 62407514, 62538842, 62662172, 62766074, 62410673, 62542958, 62668654

Knee Instrument Fixation Screws, Knee Stem Extensions & Impactor Sleeve
Recall Date: July 22, 2014 (972,125 units)

Lot Numbers: Part Number: 6290-00-702. Lots Manufactured by Zimmer: 1324203, 1339203, 1346701, 1363348, 1373979, 1382208, 1385813, 1391253, 1421647, 1437118, 1440906, 1440943, 1451869, 1464915, 1469681, 1470531, 1472373, 1474483, 1538141, 1549267, 1552408, 1554291, 1554292, 1567743, 1598694, 1601263, 1601606, 1606096, 1606957, 170454, 172361, 173342-10, 173342-3, 173342-8, 173342-9, 596146, 597424, 60278535, 60305599, 60319668, 60426581, 60557544, 60712149, 60767845, 60931683, 60946366, 60947929, 60968638, 60970621, 60986924, 60986941, 61025150, 61037537, 61080336, 61080337, 61088939, 61099737, 61099765, 61105152, 61149082, 61240132, 61444750, 61588175, 61799358, 62007189, 62043610, 62123986, 62156012, 62192074, 62216444, 62253081, 62298037, 62304814, 62353344, 625039, 62575710, 640562, 731461, 752886, 783833, 784261, 784530, 789465, 789470, 791153, 791158, 796231, 802256, 803819, 810082, 825360-1, 825360-2, 833061-1, 863221-1, & 869007.

Lots Manufactured by Centerpulse: 10249, 95077, 95316, 95317, 95655, 95656, 96228, 97923, 97923, 97924, 97925, 97926, 97927, 97928, 1141805, 1142824, 1146537, 1146538, 1146673, 1154080, 1155982, 1160641, 1164199, 1164200, 1164232, 1164233, 1179234, 1179235, 1179236, 1179237, 1179238, 1190951, 1190952, 1190953, 1190954, 1190955, 1202697, 1202698, 1202699, 1202700, 1202701, 1202702, 1202703, 1202704, 1202705, 1202706, 1204532, 1238469, 1238470, 1238471, 1238472, 1238473, 1238474, 1238475, 1267914, 1268394, 1268395, 1268396, 1268397, 1299414, 1299415, 1299416, 1306226, 1306227, 1308485, 1308486, 1313079, 1324203, 1332585, 1332695, 1339203, 1340513, 1346701, 1351209, 1353798, 1363348, 1371128, 1373979, 1382208, 1382209, 1385813, 1391253, 1421647, 1437118, 1440906, 1440943, 1451869, 1464915, 1469681, 1470531, 1472373, 1474483, 1538141, 1549267, 1552408, 1554291, 1554292, 1567743, 1583624, 1583727, 1594531, 1594583, 1595925, 1598694, 1601263, 1601606, 1606096, 1606957, 1299414-A, 1299419-A, & 95315-A

Persona The Personalized Knee System – Tibial General Instrument Tray
Recall Date: July 1, 2014 (190 units)

Lot Numbers: 56519125, 56518861

NexGen Complete Knee Solution
Recall Date: May 19, 2014 (41,180 units)

Lot Numbers: Size 1, includes the following Lot numbers:, 37217848, 61424993, 61507222, 61543969, 61774117, 62141262, 62193298, 62251564, 62261955, 62383353, 62602809, 62602810, 62602811

Gender Solutions Natural-Knee – Flex System
Recall Date: February 25, 2014 (3,638 units)

Lot Numbers: Item Numbers, 00541800000, 00541800001, 00541800002

NexGen Complete Knee Solution – Patella Drill Guide
Recall Date: November 19, 2013 (641 units)

Lot Numbers: Part Number 00-5879-067-29

Articular Surface Provisional
Recall Date: November 19, 2013 (625 units)

Lot Numbers: Part Number 00-5879-067-26

NexGen Complete Knee Solutions Stemmed Tibial Component Precoat
Recall Date: October 31, 2013 (128 units)

Lot Numbers: 00-5980-037-02; lot 6228417

Natural-Knee Flex – Femoral Component
Recall Date: August 30, 2013 (33,987 units)

Lot Numbers: Part Number Range: 00-5410,5412,5414,and 5416-013/018-01/02

Natural Knee II – Femoral Component
Recall Date: August 30, 2013 (13,483 units)

Lot Numbers: Part Number Range:6212, 6307-00-006/051

Zimmer Unicompartmental Knee – Femoral Component
Recall Date: August 30, 2013 (32,537 units)

Lot Numbers: Part Number Range:00-5842-011/017-01/02

Persona The Personalized Knee System – Tibial Articular Surface
Recall Date: June 10, 2013 (70,986 units)

Lot Numbers: 62342526, 62423918, 62423919, 62423920, 62427414, 62482212, 62563745, 62612225, 62656072, 62740698, 62342527, 62405895, 62430401, 62504179, 62511925, 62563784, 62638665, 62695870, 62343066, 62406967, 62432146, 62515486, 62564324, 62691390, 62717335, 62351291, 62374838, 62415307, 62430397, 62518138, 62622527, 62696875, 62357867, 62374796, 62427836, 62441229, 62511924, 62565948, 62563908, 62590523, 62695295, 62361315, 62376662, 62420192, 62434748, 62518137, 62540059, 62563778, 62627131, 62698733

NexGen Cruciate Retaining Complete Knee System – Micro Femurs, Articular Surface, Patellae
Recall Date: June 7, 2013 (192,355 units)

Lot Numbers: All lot numbers

Persona Knee System – Natural Tibia, Tibial Sizing Plate, Tibial Drill, Tibial Drill Guide, Tibial Broach
Recall Date: November 14, 2012 (591 units)

Lot Numbers: Part Number 42-5320-071-01 TIBIA SIZE E, LEFT, Lot 11005332, 11005333, 11005334, 11005359, 11005360, 11005361, 11006133, 11006134, 11006135, 11006136, 11006137, 11006138, 11006712, 11007124, 61956760, 61956761, 61956762, 61978561, 61978562, 61978563, 62022179, 62030574, 62033389, 62079745, 62030575, 11007596, 62091364, 62103722, 62060744, 62068418, 62079746, 62103723, 62110198, 62117658, 62076580, 62128899, 11007595, 11007597, 62144992, 62150529, 62150530

Part Number 42-5320-071-02 TIBIA SIZE E RIGHT, Lot 11006515, 11007238, 11007574, 11007575, 11007576, 62018345, 62018346, 62022180, 62022181, 62033391, 62051023, 62051801, 62068419, 62076582, 62079747, 62079761, 62103725, 62110199, 62117659, 62128904, 11007641, 11007640, 11007642

NexGen CompleteKnee Solution – Stemmed Nonaugmentable Tibial component
Recall Date: September 21, 2012 (123 units)

Lot Numbers: 62049114 and 62045235