Home / Recalls / Stelkast Co / Z-1066-2013

Z-1066-2013 Class II Terminated

Recalled by Stelkast Co — Mcmurray, PA

Recall Details

Product Type: Devices
Report Date: April 17, 2013
Initiation Date: January 24, 2013
Termination Date: October 8, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 254

Product Description

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.

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.

Distribution Pattern

Nationwide Distribution including the states of NV, OK and PA.

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.