iTotal PS Knee Replacement System — Class II medical device recall Z-1628-2020
Terminated recall by Conformis, Inc., reported 2020-04-08, distributed nationwide. A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong
| Recall number | Z-1628-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Conformis, Inc., Billerica, MA, United States |
| Recall initiated | 2020-02-03 |
| Classified | 2020-04-01 |
| Reported by FDA | 2020-04-08 |
| Terminated | 2020-12-02 |
| Distributed | Nationwide (US) |
| Quantity | 2 |
| Reason classes | labeling |
| Model numbers | TPS-111-1111-010101 |
Product
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR 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
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
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-1628-2020. 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.