Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumat
FDA device recall Z-0371-2010 · posted 2009-11-20 · Terminated
Recall details
- Recalling firm
- Stelkast Co
- Reason for recall
- incorrect size markings on component
- Action taken
- The recalling firm telephoned the medical supply companies on 5/5-19/09 to inform them of the problem and the need to return the products. If there are questions regarding this issue, please call 1.888.273.1583.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HSX
- Quantity affected
- 20 units
- Distribution
- Nationwide
- Date initiated
- 2009-05-05
- Date posted
- 2009-11-20
- Date terminated
- 2009-11-20
- Location
- Mcmurray, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STELKAST UNICONDYLAR KNEE SYSTEM (K032824) | Stelkast Company | 2003-11-13 |