Home / Recalls / Medical Devices
Stelkast Co recalls Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52.
Recalled April 17, 2013 · FDA recall Z-1066-2013 · Stelkast
Hazard
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. · FDA Class II
Units
254
Sold at
Nationwide Distribution including the states of NV, OK and PA.
Description
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.
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.
Manufacturer(s)
Stelkast Co
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →