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U.S. Department of Health and Human Services

Class 2 Device Recall Ovation Hip Stem, REF 2010002, Hip Stem Inserter, NonSterile, Ortho Development, Draper

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  Class 2 Device Recall Ovation Hip Stem, REF 2010002, Hip Stem Inserter, NonSterile, Ortho Development, Draper see related information
Date Initiated by Firm January 11, 2011
Date Posted March 16, 2011
Recall Status1 Terminated 3 on November 04, 2011
Recall Number Z-1670-2011
Recall Event ID 57747
510(K)Number K062775  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly.
Code Information All lots
Recalling Firm/
Manufacturer		 Ortho Development Corporation
12187 South Business Park Dr
Draper UT 84020
For Additional Information Contact
801-619-3450
Manufacturer Reason
for Recall		 Component of total hip arthroplasty may break during surgical procedure.
FDA Determined
Cause 2		 Process design
Action Ortho Development Corporation notified Field representatives of the issue and conditions that could lead to failure by e-mail on December 14, 2010. Redesigned product is being produced for replacement. For questions regarding this recall call 801-619-3450.
Quantity in Commerce 33 units
Distribution Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.
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 = LZO and Original Applicant = ORTHO DEVELOPMENT CORP.
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