FDAClass IIFebruary 20, 2019

21Y14 PushValve Product Usage: The PushValves recall

21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a…

Why was 21Y14 PushValve Product Usage: The PushValves recalled?

Some of the installed valve-inserts have a diameter smaller than the specification.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018

Product
21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a…
Recalling firm
Ottobock Orthopedic Industrie
Quantity
538 units
Distribution
US Nationwide Distribution
Recall date
February 20, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls