Device product
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
Z-1066-2013
Product summary
- Firm
- Stelkast Co
- Event
- Event 64505
- Status
- Terminated
- Classification
- Class II
- Quantity
- 254
- Official record key
device-enforcement:Z-1066-2013
Official wording
Reason: 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.
Code information: Part Numbers SC3458-52, lot number 28820-112612; SC3474-52, lot number 28822-101812; SC3459-52, lot number 28823-101812; and SC3460-52, lot number 28821-000.
Distribution pattern: Nationwide Distribution including the states of NV, OK and PA.
Derived failure modes
-
Unknown
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.