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U.S. Department of Health and Human Services

Class 2 Device Recall 21Y14 PushValve

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  Class 2 Device Recall 21Y14 PushValve see related information
Date Initiated by Firm January 10, 2019
Create Date February 13, 2019
Recall Status1 Terminated 3 on June 22, 2021
Recall Number Z-0826-2019
Recall Event ID 81926
Product Classification Joint, knee, external limb component - Product Code ISY
Product 21Y14 PushValve

Product Usage:

The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
Code Information The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018
Recalling Firm/
Manufacturer		 Ottobock Orthopedic Industrie
Max-Nader Str 15 D-37ns
Duderstadt Germany
Manufacturer Reason
for Recall		 Some of the installed valve-inserts have a diameter smaller than the specification.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by email on 01/10/2019 and followed with a letter on 01/11/2019. The letter identified the affected product, problem, actions to be taken and that a second letter with the replacement unit was forthcoming.
Quantity in Commerce 538 units
Distribution US 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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