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Recall Observatory FDA recall evidence

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

January 24, 2013

Class II

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

    reason.no_named_rule · v1.0.0

    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.