Ossur Engineering, Inc: Icelock Expulsion Valve 551 Model L-551000 The valve has a push button for suction release to release a lower limb prosthesis.

Recall number

Z-2026-2009

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.

Status

Terminated

Initiated

2009-06-23

Posted

2009-09-04

Terminated

2012-03-06

Reason

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

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

4,647

Distribution

Worldwide Distribution

Lot, serial or model codes

Lot CO081010

510(k) numbers

not on file

PMA numbers

not on file

Product code

ISP

Firm FEI

3002440200

Firm city

Albion

Firm state

MI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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