FDA Medical Device Recalls (openFDA)
Allen Medical Systems: Allen A-91000 Shoulder Positioner
- Recall number
- Z-0722-05
- Recalling firm
- Allen Medical Systems
- Product
- Allen A-91000 Shoulder Positioner
- Status
- Terminated
- Initiated
- 2005-03-04
- Posted
- 2005-04-22
- Terminated
- 2006-05-02
- Reason
- Shoulder positioner may break near the rail that attaches to the operating table
- Root cause
- 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
- 78 units
- Distribution
- Nationwide Foreign: Australia, Greece, Italy, Ireland
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FWZ
- Firm FEI
- not on file
- Firm city
- Acton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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