Z-2026-2009

Icelock Expulsion Valve 551 Model L-551000 The valve has a push button for suction release to release a lower...

Name: Z-2026-2009 Icelock Expulsion Valve 551 Model L-551000 The valve has a push button for suction release to release a lower...
Creator: Ossur Engineering, Inc
Published: 2009-06-23
License: https://open.fda.gov/license/

Ossur Engineering, Inc / initiated 2009-06-23 / Terminated

FDA source

Ossur Engineering, Inc began a recall of Icelock Expulsion Valve 551 Model L-551000 The valve has a push button for suction release to release a lower limb prosthesis on 2009-06-23. The reason FDA records is "The plastic caps have come off or become loose when the user stepped into their prosthesis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2026-2009
Status: Terminated
Initiated: 2009-06-23
Posted: 2009-09-04
Terminated: 2012-03-06
Recalling firm: Ossur Engineering, Inc
Product: Icelock Expulsion Valve 551 Model L-551000 The valve has a push button for suction release to release a lower limb prosthesis.
Product code: ISP Valve, Prosthesis
Reason for recall: The plastic caps have come off or become loose when the user stepped into their prosthesis.
FDA root cause: Process change control
Action: Customers were sent a Safety Notice Voluntary Product Recall, dated June 23, 2009, that advised them to return any unused valves to Ossur for a free replacement. Those using valves in combination with a cushion liner and suspension sleeve should replace immediately if problems are experienced, otherwise replace at next routine service. Customers using valve in combination with an Iceross Seal-In liner should replace ASAP and return used valves to Ossur for free replacement. Customers with questions can call Darlyne Roa 1-800-233-6263 ext 1023743.
Quantity in commerce: 4,647
Distribution: Worldwide Distribution
Product codes and lots: Lot CO081010

Product code ISP

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)