Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1
FDA Recall Z-0953-03 · Posted 2003-06-27
Recalling FirmThe OR Group,Inc.
Recall StatusTerminated
Product CodeFWZ
Date Initiated2003-06-02
Date Terminated2016-02-02
Product Quantity460 units
Reason for Recall
Foot Stirrups may detach from mount when user is locking system
Firm Action
The OR Group notifed the accounts by letter sent Air Borne on 6/6/03 advising users to return the stirrups. The firm will inspect and repair the returned units. The firm expanded the recall to include units manufactured between August 02 and May 03. Recall letters were issued on 9/18/03 via Fed'X with instructions to test and identify the device for correct measurement.
Root Cause
Other
Distribution Pattern
Nationwide Foreign: Australia, Korea, Italy, Hong Kong, Ireland, Czech republic, South Africa,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.