FDA-Device2013-04-17Class II
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.
Stelkast Co
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.
Sold states
Nationwide Distribution including the states of NV, OK and PA.
Affected count
254
Manufactured in
200 Hidden Valley Rd, Mcmurray, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1066-2013Don't want to check this manually?
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