ClearanceBrief
Recall Z-0722-05 ยท FWZ Operating Room Accessories Table Tray

Allen Medical Systems

Allen A-91000 Shoulder Positioner

DateApr 22, 2005 (initiated Mar 4, 2005)
StatusTerminated
ReasonShoulder positioner may break near the rail that attaches to the operating table
Root causeOther
ActionAllen Medical notified consignees by letter dated 3/4/05 via Fed''X. Facilities are requested to remove the shoulder positioner and return it per the listed instructions .
Quantity78 units
DistributionNationwide Foreign: Australia, Greece, Italy, Ireland
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.