Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0826-2019 · Posted None

Recalling FirmOttobock Orthopedic Industrie
Recall StatusTerminated
Product CodeISY
Date Initiated2019-01-10
Date Terminated2021-06-22
Product Quantity538 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.

↑