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

FDA device recall Z-2026-2009 · posted 2009-09-04 · Terminated

Recall details

Recalling firm

Ossur Engineering, Inc

Reason for recall

The plastic caps have come off or become loose when the user stepped into their prosthesis.

Action taken

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

Status

Terminated

Product code

ISP

Quantity affected

4,647

Distribution

Worldwide Distribution

Date initiated

2009-06-23

Date posted

2009-09-04

Date terminated

2012-03-06

Location

Albion, MI