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Terminated

21Y15 MagValve 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.

FDA Recall Z-0828-2019 · Posted None

Recalling FirmOttobock Orthopedic Industrie
Recall StatusTerminated
Product CodeISY
Date Initiated2019-01-10
Date Terminated2021-06-22
Product Quantity110 units

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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