Reported Feb 20, 2019 · Terminated
21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower…
Ottobock Orthopedic Industrie
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ottobock Orthopedic Industrie · Max-Nader Str 15 D-37ns · Duderstadt, N/A · N/A
Is this the product you have?
- 21Y15
- MagValve Product UsageThe 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
- Lot codes and dates
- The products with an article number listed below and delivered between May 1, 2017 and January 19, 2018
- Amount recalled
- 110 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Some of the installed valve-inserts have a diameter smaller than the specification.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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