PSI Knee System- Prosthesis — Class II medical device recall Z-0495-2015
Terminated recall by Zimmer CAS, reported 2014-12-10, distributed in AZ, CO, IL, OR, WA. Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustment
| Recall number | Z-0495-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer CAS, Montreal, N/A, Canada |
| Recall initiated | 2014-11-03 |
| Classified | 2014-12-02 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-02-13 |
| Distributed | AZ, CO, IL, OR, WA |
| Quantity | 15 |
| Expiration dates | 2014-05-08 |
Product
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
Reason for recall
Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw.
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-0495-2015. 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.