Zimmer, Inc.: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.

Recall number

Z-2035-2014

Recalling firm

Zimmer, Inc.

Product

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.

Status

Terminated

Initiated

2014-05-23

Posted

2014-07-10

Terminated

2015-03-06

Reason

Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.

Root cause

Packaging

Action

Zimmer sent an Medical Device Recall Letter on June 4, 2014, to their Distributors. On June 9, 2014, Zimmer sent Medical Device Recall Letters to the physicians. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. Locate all products from the affected lots and quarantine them immediately, if not previously done so per the May 23, 2014 Notice of Suspension of Loaner Pool. 2. Confirm the physical count of all affected product in loaner pool in your territory and complete the Confirmation of Loaner Pool Inventory and Return Certification Form (Attachment 2), and email a completed copy of Attachment 2 to corporatequality.postmarket@zimmer.com. 3. Return the recalled product along with the completed Confirmation of Loaner Pool Inventory and Return Certification Form (Attachment 2). 4. Identify additional customers that may have used this product in the past 12 months by completing the spreadsheet template provided to you via email or confirm that Zimmer has identified all current customers in your territory. 5. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Quantity

315 units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.

Lot, serial or model codes

Product ID: 00771300500, Lot #: 61694618, 61743290, 61812682, 61845568, 61845569, 61972395, 61972396, 61978915, 62030113, 62044919, 62118875, 62134957, 62163650, 62169474, 62225879, 62225880, 62354721, 62418036, 62418040, 62460390, 62478289, 62586736 & 62687940.  Product ID: 00771300600, Lot #: 60958672, 61468347, 61768416, 61945209, 62071403, 62179055, 62198165, 62238299, 62243210, 62361446, 62422692, 62425093, 62425097, 62430583, 62460385, 62478293, 62484262, 62528055, 62554084, 62616549, 62667448, 62681512 & 77002699.  Product ID: 00771300700, Lot #: 61856468, 61950857, 61985935, 62118858, 62153527, 62163657, 62247195, 62275860, 62361448, 62361449, 62414878, 62414882, 62418044, 62454089, 62454091, 62454093, 62489358, 62521396, 62528063, 62554092, 62578361, 62614850, 62652926, 62659300 & 62681516.  Product ID: 00771300900, Lot #: 61548886, 62225891, 62282073, 62335405, 62335409, 62356148, 62361455, 62367790, 62414880, 62417690, 62472139, 62484266, 62489363, 62496069, 62521565, 62530628, 62540514, 62554103, 62564692, 62578368, 62578370, 62652933, 62667455 & 62700933.  Product ID: 00771301000, Lot #: 61356738, 61796994, 61850999, 62030070, 62124949, 62169497, 62198185, 62253484, 62288848, 62342743, 62342963, 62342967, 62367798, 62367799, 62443121, 62443123, 62503161, 62560129, 62564694, 62564698, 62578377, 62594161, 62652941, 62652942, 62667463, 62694065 & 77003232.  Product ID: 00771301100, Lot #: 61576325, 61786474, 61909829, 61950874, 62066981, 62163668, 62201722, 62207778, 62253492, 62417698, 62428479, 62432955, 62432959, 62450085, 62496079, 62521571, 62521572, 62540529, 62554121, 62564702, 62578385, 62616557, 62647175, 62647178, 62659302, 62667466 & 62667469.  Product ID: 00771301200, Lot #: 60898841, 61300903, 61409710, 62030078, 62041818, 62163670, 62198191, 62207784, 62253638, 62270938, 62282101, 62356206, 62418052, 62428484, 62428488, 62432966, 62478323, 62484283, 62496086, 62503168, 62521407, 62546967, 62546968, 62546975, 62564705, 62578401, 62659306 & 62687964.  Product ID: 00771301300, Lot #: 61542773, 61909835, 61978950, 61998346, 62030103, 62059101, 62066988, 62176190, 62213560, 62219796, 62243241, 62350591, 62418054, 62420827, 62425109, 62484286, 62489381, 62521416, 62521419, 62578404, 62614869, 62622958 & 62681546.  Product ID: 00771301500, Lot #: 61613909, 61743314, 61894833, 61925319, 61967638, 62014552, 62014553, 62071435, 62130041, 62213563, 62225910, 62253643, 62350594, 62361478, 62420834, 62594177, 62622960 & 62652963.  Product ID: 00771301600, Lot #: 60803338, 61735132, 61781830, 61796999, 61837511, 61945229, 61945232, 61966387, 61991587, 62030114, 62041829, 62114219, 62153556, 62246579, 62420836, 62432974, 62432975, 62432976 & 77002653.  Product ID: 00771301700, Lot #: 11002955, 60815998, 60819830, 60845838, 61719863, 61741697, 61894835, 62010559, 62078152, 62101365, 62124961, 62207790, 62219802, 62253646, 62361479, 62478333, 62521429, 62564713, 62578411 & 60841248R.  Product ID: 00771302000, Lot #: 60617023, 60940201, 61326522, 61576337, 61613958, 61729730, 61985982, 62078154, 62225912, 62295421, 62356231 & 62478335.  Product ID: 00771302200, Lot #: 11001594, 11001595, 11001596, 11003622, 60617024, 60837142, 60940196, 61040881, 61081253 & 62342976.

510(k) numbers

not on file

PMA numbers

not on file

Product code

LPH

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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