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U.S. Department of Health and Human Services

Class 2 Device Recall Ortho Development Primaloc Cemented Hip System

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  Class 2 Device Recall Ortho Development Primaloc Cemented Hip System see related information
Date Initiated by Firm July 28, 2010
Date Posted November 03, 2010
Recall Status1 Terminated 3 on November 04, 2010
Recall Number Z-0315-2011
Recall Event ID 56499
510(K)Number K962448  
Product Classification Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented - Product Code KWY
Product Distal Centralizer 10 mm
Code Information Work order numbers: 0050794; 0051535; 0054967; 0055667; 0060372; 0061102; 0061769; 0062929; 0063395
Recalling Firm/
Manufacturer		 Ortho Development Corporation
12187 South Business Park Dr
Draper UT 84020
For Additional Information Contact Bob Weston
801-619-3419
Manufacturer Reason
for Recall		 The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Ortho Development sent a Field Notification Memo dated July 28, 2010 to Japan Medical Dynamic Marketing instructing them to reconcile parts that may have been used and return unused parts to Ortho. Customers can contact Ortho Development at 1-801-619-3419.
Quantity in Commerce 39 units
Distribution Worldwide Distribution: Japan
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 = KWY and Original Applicant = ORTHO DEVELOPMENT CORP.
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