Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52.
FDA device recall Z-1066-2013 · posted 2013-04-07 · Terminated
Recall details
- Recalling firm
- Stelkast Co
- Reason for recall
- Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.
- Action taken
- The firm initiated their recall of this product on January 24, 2013 by notifying their consignees by telephone informing them of the recall.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OQG
- Quantity affected
- 254
- Distribution
- Nationwide Distribution including the states of NV, OK and PA.
- Date initiated
- 2013-01-24
- Date posted
- 2013-04-07
- Date terminated
- 2014-10-08
- Location
- Mcmurray, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CROSS-OVER ACETABULAR SHELL & LINER (K122773) | Stelkast Company | 2012-10-09 |