Zimmer, Inc.: NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.

Hazard

Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.

Details from the source

Reason for recall: Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate. Distribution: Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the countries of Australia, Canada, Japan, Netherlands. Quantity: 5,546 units Lot/code info: Item No. 00595201501, 00595201502, 00595201505, 00595201506; UDI:(01)00889024207806(17)280731(10)64115713, (01)00889024207806(17)280930(10)64175075, (01)00889024207806(17)280930(10)64175076, (01)00889024207790(17)280930(10)64175073, (01)00889024207806(17)280930(10)64138317, (01)00889024207790(17)281031(10)64175074, (01)00889024207790(17)281031(10)64194991, (01)00889024207790(17)281031(10)64202116, (01)00889024207806(17)281031(10)64178998, (01)00889024207813(17)281031(10)64179054, (01)00889024207790(17)281031(10)64202117, (01)00889024207813(17)281031(10)64179043, (01)00889024207813(17)281031(10)64194989, (01)00889024207790(17)281031(10)64178996, (01)00889024207790(17)281031(10)64178997, (01)00889024207790(17)281031(10)64179023, (01)00889024207820(17)281031(10)64178999, (01)00889024207813(17)281031(10)64179043R, (01)00889024207813(17)281031(10)64194989R, (01)00889024207790(17)281130(10)64202115, (01)00889024207790(17)281130(10)64226003, (01)00889024207806(17)281130(10)64226007, (01)00889024207806(17)281130(10)64226008, (01)00889024207820(17)281130(10)64220651, (01)00889024207790(17)281130(10)64226001, (01)00889024207806(17)281130(10)64226006, (01)00889024207806(17)281130(10)64202119, (01)00889024207790(17)281130(10)64226002, (01)00889024207806(17)281130(10)64202118, (01)00889024207790(17)281231(10)64254389, (01)00889024207806(17)281231(10)64254390, (01)00889024207806(17)281231(10)64226077, (01)00889024207806(17)281231(10)64226078, (01)00889024207806(17)281231(10)64226009, (01)0

UPC codes

00595201501, 00595201502, 00595201505, 00595201506, 00889024207806, 00889024207790, 00889024207813, 00889024207820

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.