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U.S. Department of Health and Human Services

Class 2 Device Recall Ossur Elation

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  Class 2 Device Recall Ossur Elation see related information
Date Initiated by Firm October 21, 2005
Date Posted January 12, 2006
Recall Status1 Terminated 3 on March 20, 2007
Recall Number Z-0388-06
Recall Event ID 34013
Product Classification Component, External, Limb, Ankle/Foot - Product Code ISH
Product Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.
Code Information Serial Numbers: 5927, 5930, 5935, 5936, 5937, 5938, 5939, 5940, 5941, 5942, 5943, 5944, 5945, 5947, 5948, 5949, 5950, 5951, 5954, 5955, 5956, 5959, 5960, 5961, 5962, 5964, 5965, 5970, 5971, 5972, 5973, 5974, 5975, 5977, 5978, 5979, 5980, 6015, 6016, 6020, 6027, 6028, 6031, 6032.
Recalling Firm/
Manufacturer		 Ossur
Grjothals 5
Reykjavik Ireland
For Additional Information Contact Johanna Valdimarsdottir
354-515-1300
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 48 (23 in US)
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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