FDA Device recall Z-2849-2020
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT…
- FDA Device
- Class II
- terminated
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II recall of Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT… by Conformis, citing outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2849-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-20 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Conformis |
| Distribution | NV |
Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Reason
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Identifiers
| code_info | Serial Number: 0469247 Exp. 2021-01-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2849-2020%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.