iTotal Posterior Stabilized — Class II medical device recall Z-1079-2019
Terminated recall by Conformis, Inc., reported 2019-04-10, distributed in NH. The labeling of the boxes and sterile pouches did not match the contents.
| Recall number | Z-1079-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2019-01-04 |
| Classified | 2019-03-30 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2020-06-29 |
| Distributed | NH |
| Countries outside the US | DE |
| Quantity | 2 |
| Reason classes | labeling, sterility |
| Serial numbers | 0434436, 0434836 |
| Model numbers | 020102, TPS-111-1111 |
Product
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Reason for recall
The labeling of the boxes and sterile pouches did not match the contents.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1079-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.