FDA Device recall Z-1608-2024
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System by Zimmer, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1608-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-28 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Zimmer |
| Distribution | US |
Product
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Reason
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.
Identifiers
| code_info | Item No. 00595201501, 00595201502, 00595201505, 00595201506; UDI:(01)00889024207806(17)280731(10)64115713, (01)00889024…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)00889 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1608-2024%22
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