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U.S. Department of Health and Human Services

Class 2 Device Recall Allen Medical

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  Class 2 Device Recall Allen Medical see related information
Date Initiated by Firm March 04, 2005
Date Posted April 22, 2005
Recall Status1 Terminated 3 on May 02, 2006
Recall Number Z-0722-05
Recall Event ID 31329
Product Classification Operating Room Accessories Table Tray - Product Code FWZ
Product Allen A-91000 Shoulder Positioner
Code Information Serial Numbers:  260227 260228 260229 260230 262208 A032121 A032122 A032123 A032124 A032125 A032126 A032128 A032129 A032340 A032942 A032944 A033038 A033039 A033040 A033920 A033921 A033922 A033923 A033924 A033925 A033927 A033928 A033929 A034241 A034242 A034243 A034623 A034624 A034626 A034627 A034628 A034877 A034907 A034909 A035239 A035242 A035243 A035623 A035624 A035625 A037489 A040087 A040359 A040360 A040361 A040362 A040363 A040364 A040650 A040693 A040694 A040778 A040779 A040780 A040781 A040782 A041742 A041743 A041744 A041745 A041746 A041747 A042080 A042081 A042082 A042159 A042533 A042534 A042640 A042641 A043683 A043684 A043953 
Recalling Firm/
Manufacturer		 Allen Medical Systems
One Post Office Square
Acton MA 01720-3934
For Additional Information Contact Nancy Royalty
877-458-4884 Ext. 259
Manufacturer Reason
for Recall		 Shoulder positioner may break near the rail that attaches to the operating table
FDA Determined
Cause 2		 Other
Action Allen 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 .
Quantity in Commerce 78 units
Distribution Nationwide Foreign: Australia, Greece, Italy, Ireland
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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