Z-2035-2014Class II

Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11...

Name: Z-2035-2014 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11...
Creator: Zimmer, Inc.
Published: 2014-05-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-05-23 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of 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... on 2014-05-23. FDA classified it as Class II and gives the reason as "Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2035-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-23
Posted: 2014-07-10
Terminated: 2015-03-06
Recalling firm: Zimmer GmbH
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.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Root cause tag: packaging
FDA 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 [email protected]. 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 in commerce: 315 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2035-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2033-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-10
Z-2034-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-10
Z-2035-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-10

Product code LPH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)