ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog… — Class II medical device recall Z-0991-2017
Terminated recall by ConforMIS, Inc., reported 2017-01-18, distributed in TX. iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
| Recall number | Z-0991-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConforMIS, Inc., Bedford, MA, United States |
| Recall initiated | 2016-10-31 |
| Classified | 2017-01-10 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-01-11 |
| Distributed | TX |
| Quantity | 1 units |
| Serial numbers | 0384180 |
| Model numbers | TPS-111-1111 |
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 for recall
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
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-0991-2017. 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.