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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

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.
Recall Number Z-1066-2013
Classification Class II
Code Info 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.
Product Distributed Qty 254
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.

Event Detail

Event Id 64505
Product Type Devices
Status Ongoing
Recalling Firm Stelkast Co
City Mcmurray
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-24
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide Distribution including the states of NV, OK and PA.