FDA Device recall Z-0991-2017
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a tota…
- FDA Device
- Class II
- terminated
- Published 2017-01-18
On 2017-01-18 the FDA classified a Class II recall of ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a tota… by Conformis, citing iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0991-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-31 |
| Published | 2017-01-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Conformis |
| Distribution | TX |
Product
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
Reason
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Identifiers
| code_info | Serial Number: 0384180 |
|---|
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-0991-2017%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.