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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 Recall
Stelkast Crossover Acetabular Shell and Liner Hip System
see related information
Date Posted April 07, 2013
Recall Status1 Open
Recall Number Z-1066-2013
Recall Event ID 64505
Premarket Notification
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, Pennsylvania 15317-2659
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OQG and Original Applicant = STELKAST COMPANY
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