FDA Device recall Z-1079-2019
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
- FDA Device
- Class II
- terminated
- Published 2019-04-10
On 2019-04-10 the FDA classified a Class II recall of iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102 by Conformis, citing the labeling of the boxes and sterile pouches did not match the contents.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1079-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-04 |
| Published | 2019-04-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Conformis |
| Distribution | NH |
Product
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Reason
The labeling of the boxes and sterile pouches did not match the contents.
Identifiers
| code_info | Serial Numbers 0434436 and 0434836 |
|---|
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-1079-2019%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.