Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0
FDA device recall Z-0388-06 · posted 2006-01-12 · Terminated
Recall details
- Recalling firm
- Ossur
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- ISH
- Quantity affected
- 48 (23 in US)
- Distribution
- Nationwide
- Date initiated
- 2005-10-21
- Date posted
- 2006-01-12
- Date terminated
- 2007-03-20
- Location
- Reykjavik, Ireland
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