Z-0388-06

Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers...

Name: Z-0388-06 Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers...
Creator: Ossur
Published: 2005-10-21
License: https://open.fda.gov/license/

Ossur Iceland ehf. / initiated 2005-10-21 / Terminated

FDA source

Ossur began a recall of Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &... on 2005-10-21. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0388-06
Status: Terminated
Initiated: 2005-10-21
Posted: 2006-01-12
Terminated: 2007-03-20
Recalling firm: Ossur Iceland ehf.
Product: Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR.
Product code: ISH Component, External, Limb, Ankle/Foot
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 root cause: 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
Product codes and lots: 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.

Product code ISH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)