Class 2 Device Recall Modular Polycentric EBS Knee Joint

• Date Initiated by Firm: January 04, 2016
• Create Date: February 01, 2016
• Recall Status: Terminated on May 02, 2016
• Recall Number: Z-0608-2016
• Recall Event ID: 72960
• Product Classification: Joint, knee, external limb component - Product Code ISY
• Product: Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
• Code Information: All serviced between 27 April 2015 and 17 November 2015
• Recalling Firm/ Manufacturer: Otto Bock Healthcare GmbH; Max-Nader-Str. #15; Duderstadt Germany
• For Additional Information Contact: Lex J. Pearce; 801-971-6618
• Manufacturer Reason for Recall: Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced between 27 April 2015 and 17 November 2015 due to a service error where the wrong Loctite was used during repair.
• FDA Determined Cause: Process control
• Action: Starting Jan 4 2016, In coordination with the Manufacturer, the US Agent will notify customers via telephone call of the correction on behalf of the Manufacturer. The customers will be requested to return the affected devices back to the service center for correction. The devices will be returned to the customer following correction.
• Quantity in Commerce: 40 units
• Distribution: Nationwide 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.