FDA Device recall Z-0145-2016
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OU…
- FDA Device
- Class II
- terminated
- Published 2015-10-28
On 2015-10-28 the FDA classified a Class II recall of ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OU… by Conformis, citing may contain small amounts of ethylene glycol residue.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0145-2016 |
| 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 (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
Reason
May contain small amounts of ethylene glycol residue
Identifiers
| code_info | Serial Numbers (US): 0348488 0355066 0355392 0355317 0353561 0354483 0354945 0355261 0355989 0347842 035556…Serial Numbers (US): 0348488 0355066 0355392 0355317 0353561 0354483 0354945 0355261 0355989 0347842 0355561 0351297 0354882 0354343 0354746 0356253 0355288 0351033 0354279 0354994 0352643 0353878 0354579 0353642 0353612 0353882 0352852 0354051 0355244 0354198 0353638 0355030 0354485 0352979 0355292 0354752 0354992 0354915 0355643 0355534 0354406 0354834 0355706 0353989 0355877 0355175 0352628 0354616 0354740 0353368 0352993 0354481 0354768 0355262 0355375 0353458 0355484 0355865 0336962 0355154 0353183 0353452 0352902 0353126 0353139 0353927 0354087 0353911 0355624 0355128 0354275 0354378 0352822 0353001 0353300 0353327 0352113 0354712 0354918 0354813 0353104 0353705 0352746 0353487 0354216 0353915 0354542 0354690 0354875 0354151 0354522 0355219 0355499 0351896 0351998 0354374 0354730 0354923 0354800 0353898 0354486 0354056 0354952 0354213 0354342 0353964 0353717 0354837 03534 |
|---|
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-0145-2016%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.