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Terminated

Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.

FDA Recall Z-0388-06 · Posted 2006-01-12

Recalling FirmOssur
Recall StatusTerminated
Product CodeISH
Date Initiated2005-10-21
Date Terminated2007-03-20
Product Quantity48 (23 in US)

Reason for Recall

After one year devices assembled with a new type of O-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot.

Firm Action

Telephone communication followed by notification letter mailed to end users (patients) and prosthetics workshops. A pre-paid package to return faulty components to Ossur included with mailed letters. New replacement feet will be shipped to customers.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

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

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