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U.S. Department of Health and Human Services

Class 2 Device Recall Ottobock Pheon 3R62 Knee Joint

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  Class 2 Device Recall Ottobock Pheon 3R62 Knee Joint see related information
Date Initiated by Firm July 16, 2015
Date Posted July 24, 2015
Recall Status1 Terminated 3 on June 21, 2017
Recall Number Z-2261-2015
Recall Event ID 71715
Product Classification Joint, knee, external limb component - Product Code ISY
Product Ottobock Pheon 3R62 Knee Joint

The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
Code Information The removal affects all devices manufactured and distributed since February 2014.
Recalling Firm/
Manufacturer		 Otto Bock Healthcare GmbH
Max-Nader-Str. #15
Duderstadt Germany
For Additional Information Contact Lex J. Pearce
800-328-4058
Manufacturer Reason
for Recall		 Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions which may result in a fall.
FDA Determined
Cause 2		 Component design/selection
Action The firm, Ottobock, sent an "URGENT MEDICAL DEVICE RECALL 3R62 Pheon" letter dated 16 July 2015 to its customers. The letter described the product, problem, and actions to be taken. The customers instructed to read this notice in its entirety; examine your stock for 3R62 Pheon devices; quarantine 3R62 Pheon devices and prevent further distribution; contact Ottobock customer service at (800) 328-4058-option 1 or (512) 806-2000 -Option 1, to obtain a return authorization for those devices, and complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email to: USRecalls@ottobock.com "Pheon Recall"; fax (801) 974-6718-"Pheon Recall" or mail to: Otto Bock HealthCare LP, ATTN: PHEON RECALL, 3820 W. Great Lakes Drive, Salt Lake City, UT 84120-B7 is re-designing the locking function to prevent this failure from occurring. The re-designed devices will be available for replacement sometime within the next few months. If you have any questions contact Director, Regulatory & Quality Compliance at (801) 974-6618 or email: Lex.Pearce@ottobock.com.
Quantity in Commerce 518 (439 US; 79 OUS)
Distribution Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
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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