Class 2 Device Recall Pivot BiPolar Head

• Date Initiated by Firm: April 29, 2009
• Date Posted: October 28, 2009
• Recall Status: Terminated on May 25, 2010
• Recall Number: Z-0086-2010
• Recall Event ID: 52048
• 510(K)Number: K050966
• Product Classification: hip prosthesis - Product Code KWY
• Product: Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
• Code Information: Part 133-2846, Lots 3370, 3534, 3620, 3731 Part 133-2847, Lots 3492, 3535 Part 133-2848, Lot 3509 Part 133-2851, Lot 3433 Part 133-2852, Lot 3661
• 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: A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.
• FDA Determined Cause: Device Design
• Action: Ortho sent a Field notification Memo dated 4/2/2009 to agents and distributors, giving them pre-implant examination guidelines. Decision to recall non-implanted units was made on 4/29/2009 and this was communicated by telephone to distributors.
• Quantity in Commerce: 23
• Distribution: AZ, CA, FL, MA, MI. No military, government or foreign distribution.
• 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.