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U.S. Department of Health and Human Services

Class 2 Device Recall Modular Polycentric EBS Knee Joint

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  Class 2 Device Recall Modular Polycentric EBS Knee Joint see related information
Date Initiated by Firm January 04, 2016
Create Date February 01, 2016
Recall Status1 Terminated 3 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 2		 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.
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