Icelock Expulsion Valve 551 Model L-551000 The valve has a push button for suction release to release a lower limb prosthesis.
FDA Recall Z-2026-2009 · Posted 2009-09-04
Recalling FirmOssur Engineering, Inc
Recall StatusTerminated
Product CodeISP
Date Initiated2009-06-23
Date Terminated2012-03-06
Product Quantity4,647
Reason for Recall
The plastic caps have come off or become loose when the user stepped into their prosthesis.
Firm 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.
Root Cause
Process change control
Distribution Pattern
Worldwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.