Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is… — Class II medical device recall Z-0198-2015
Terminated recall by Zimmer, Inc., reported 2014-11-19, distributed nationwide. Cleaning process validation failure.
| Recall number | Z-0198-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-10-09 |
| Classified | 2014-11-08 |
| Reported by FDA | 2014-11-19 |
| Terminated | 2015-06-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, FR, GB, IT, ZA |
| Quantity | 138 units |
| Lot numbers | 62613813, 62619031, 62619040, 62625781, 62625790, 62626696 |
| Model numbers | 42-5320-071-01, 42-5320-071-02, 42-5320-075-01, 42-5320-079-01, 42-5320-079-02 |
Product
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device is intended for cemented use only.
Reason for recall
Cleaning process validation failure.
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-0198-2015. 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.