Recall Z-2026-2009 ยท ISP Valve, Prosthesis
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.
| Date | Sep 4, 2009 (initiated Jun 23, 2009) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.