FDA Device recall Z-0146-2016
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
- FDA Device
- Class II
- terminated
- Published 2015-10-28
On 2015-10-28 the FDA classified a Class II recall of ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS) by Conformis, citing may contain small amounts of ethylene glycol residue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0146-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-31 |
| Published | 2015-10-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Conformis |
| Distribution | US |
Product
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
Reason
May contain small amounts of ethylene glycol residue
Identifiers
| code_info | Serial Numbers (US): 0353281 0355761 0352418 0353880 0354092 0354675 0354821 0355543 0354327 0352462 035483…Serial Numbers (US): 0353281 0355761 0352418 0353880 0354092 0354675 0354821 0355543 0354327 0352462 0354838 0352276 0355506 0355440 0353788 0354652 0349894 0350379 0352905 0354025 0355196 0355405 0355622 0351034 0353474 0353739 0354763 0354158 0355067 0354429 0354764 0353422 0354285 0355646 0355282 0354831 0353993 0355861 0354799 0355519 0353322 0355546 0355319 0355287 0353365 0353987 0355191 0356013 0352467 0354363 0350372 0354462 0355162 0355296 0355070 0354734 0352448 0354116 0353782 0353342 0353040 0355522 0354034 0354476 0354835 0353424 0351578 0353329 0353597 0354408 0354814 0352783 0352940 0352894 0353027 0353492 0352780 0353125 0353929 0353457 0354128 0352830 0354543 0353393 0350374 0353510 0353659 0354329 0354731 0352356 0353996 0353719 0353536 0354611 0353718 0353698 0355577 0355086 0354261 0355369 0352721 0354791 0353907 0354348 0354083 0354913 0353906 0353137 03542 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0146-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.