Class 2 Device Recall Ortho Development Primaloc Cemented Hip System

• Date Initiated by Firm: July 28, 2010
• Date Posted: November 03, 2010
• Recall Status: Terminated 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: 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