FDA Medical Device Recalls (openFDA)
Allen Medical Systems: Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
- Recall number
- Z-0642-2018
- Recalling firm
- Allen Medical Systems
- Product
- Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
- Status
- Terminated
- Initiated
- 2017-10-06
- Posted
- not on file
- Terminated
- 2019-04-03
- Reason
- The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
- Root cause
- Device Design
- Action
- In October of 2017 an Urgent Medical Device Correction letter was sent to customers notifying them of the recall and requesting customers to immediately remove any frames from use that are in the serial number range subject to the recall and that a service technician will coordinate correction of the device. If the device was sent to another company, to forward the recall notice o that person or firm. If you have any questions concerning this Urgent Medical Device Correction, please contact Allen Medical Customer Service at (800) 433-5774, 8:30 5:00 pm EST.
- Quantity
- 161 units total
- Distribution
- Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.
- Lot, serial or model codes
- Serial Number: 533552 536025 536451 539585 539795 535272 536026 536452 539586 542764 535273 536027 536453 539587 544938 535274 536028 536454 539588 544939 535386 536029 536455 539589 544940 535387 536030 536456 539794 546200
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JEB
- Firm FEI
- 1221538
- 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