Z-0642-2018Class II

Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine...

Name: Z-0642-2018 Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine...
Creator: Allen Medical Systems
Published: 2017-10-06
License: https://open.fda.gov/license/

Allen Medical Systems, Inc. / initiated 2017-10-06 / Terminated / root cause: design

FDA source

Allen Medical Systems began a recall of Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures on 2017-10-06. FDA classified it as Class II and gives the reason as "The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0642-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-06
Posted: 2018-02-20
Terminated: 2019-04-03
Recalling firm: Allen Medical Systems, Inc.
Product: Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Product code: JEB Table, Surgical With Orthopedic Accessories, Manual
Reason for recall: The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0642-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0641-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20
Z-0642-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20

Product code JEB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)