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U.S. Department of Health and Human Services

Class 2 Device Recall Stelkast Crossover Acetabular Shell and Liner Hip System

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  Class 2 Device Recall Stelkast Crossover Acetabular Shell and Liner Hip System see related information
Date Initiated by Firm January 24, 2013
Date Posted April 07, 2013
Recall Status1 Terminated 3 on October 08, 2014
Recall Number Z-1066-2013
Recall Event ID 64505
510(K)Number K122773  
Product Classification Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented - Product Code OQG
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.
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.
Recalling Firm/
Manufacturer		 Stelkast Co
200 Hidden Valley Rd
Mcmurray PA 15317-2659
For Additional Information Contact
724-941-6368
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action The firm initiated their recall of this product on January 24, 2013 by notifying their consignees by telephone informing them of the recall.
Quantity in Commerce 254
Distribution Nationwide Distribution including the states of NV, OK and PA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OQG and Original Applicant = STELKAST COMPANY
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