FDA Device recall Z-1070-2016
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111 by Conformis, citing incorrect femoral component distributed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1070-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-28 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Conformis |
| Distribution | KY |
Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Reason
Incorrect femoral component distributed
Identifiers
| code_info | Serial Number:0363410 UDI - M572TCR1111111021/$$316073103634108 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1070-2016%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.