| Class 2 Device Recall Ovation Hip Stem, REF 2010103, Offset Stem Inserter LT, NonSterile, Ortho Development, Draper | |
Date Initiated by Firm | January 11, 2011 |
Date Posted | March 16, 2011 |
Recall Status1 |
Terminated 3 on November 04, 2011 |
Recall Number | Z-1672-2011 |
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
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Product | Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, 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
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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 | 7 units |
Distribution | Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LZO
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