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 the
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. is recalling 315 units of Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology in sizes 4, 5, 6, 7.5, 9, 10, 11, and 12.5. Black residue has been observed in the sterile pouches of the M/L Taper and Kinectiv stems. The affected products have been distributed worldwide, including across the United States and in Australia, Canada, China, Europe, India, Japan, Korea, and Singapore.
The recall involves multiple product IDs and specific lot numbers. The record does not specify a remedy for consumers who may have received affected products.
Written by software from the official notice below. Not reviewed by a lawyer.
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Reason for recall: Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore. Quantity: 315 units Lot/code info: 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, 622
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.