Reported May 1, 2024 · Ongoing
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
- Lot codes and dates
Item No. 00595201501005952015020059520150500595201506
- UDI
284 of 284 codes
(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)00889024207790(17)281231(10)64226076(01)00889024207790(17)281231(10)64254387(01)00889024207790(17)281231(10)64254388(01)00889024207806(17)281231(10)64261032(01)00889024207806(17)281231(10)64226129(01)00889024207820(17)281231(10)64242244(01)00889024207790(17)281231(10)64254386(01)00889024207790(17)281231(10)64226076R(01)00889024207790(17)281231(10)64254386R(01)00889024207790(17)281231(10)64254387R(01)00889024207790(17)290131(10)64261030(01)00889024207790(17)290131(10)64275592(01)00889024207806(17)290131(10)64275434(01)00889024207806(17)290131(10)64261033(01)00889024207806(17)290131(10)64261035(01)00889024207790(17)290131(10)64261031(01)00889024207806(17)290131(10)64275593(01)00889024207790(17)290131(10)64261029(01)00889024207790(17)290131(10)64275538(01)00889024207806(17)290131(10)64275540(01)00889024207820(17)290131(10)64261037(01)00889024207813(17)290131(10)64261036(01)00889024207790(17)290131(10)64275537(01)00889024207806(17)290131(10)64275435(01)00889024207790(17)290131(10)64275433(01)00889024207806(17)290131(10)64275541
- Lot Code
284 of 284 codes
641157136417507564175076641750736413831764175074641949916420211664178998641790546420211764179043641949896417899664178997641790236417899964179043R64194989R6420211564226003642260076422600864220651642260016422600664202119642260026420211864254389642543906422607764226078642260096422607664254387642543886426103264226129642422446425438664226076R64254386R64254387R64261030642755926427543464261033642610356426103164275593642610296427553864275540642610376426103664275537642754356427543364275541
- Amount recalled
- 5,546 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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