Z-0641-2018Class II

Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures

Name: Z-0641-2018 Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures
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 Allen Medical Bow Frame Model A-70800. 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-0641-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-06
Posted: 2018-02-20
Terminated: 2019-04-03
Recalling firm: Allen Medical Systems, Inc.
Product: Allen Medical Bow Frame Model A-70800. 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: A402596 A404960 A407142 A408656 A411816 A415114 A416956 A402597 A404961 A407143 A408657 A411817 A415115 A416957 A402598 A404962 A407144 A408658 A411818 A415116 A416958 A402599 A404963 A407145 A409320 A411819 A415117 A416959 A402604 A404964 A407146 A409321 A411820 A415726 A416960 A402605 A404965 A407460 A409322 A412539 A415727 A416961 A402606 A404966 A407147 A409323 A412540 A415728 A417547 A402607 A405472 A407461 A409335 A412541 A415729 A417548 A402608 A405473 A407885 A409336 A412542 A416163 A417549 A402609 A405474 A407886 A410068 A412543 A416164 A417550 A402610 A405475 A407887 A410069 A412544 A416165 A417919 A402611 A405476 A407888 A410070 A412545 A416166 A543137 A403277 A405477 A407889 A410071 A412546 A416167 A403278 A405478 A407890 A410072 A413529 A416168 A403279 A405479 A407891 A410073 A413530 A416169 A403280 A405787 A407892 A410074 A413531 A416170 A403281 A405788 A407893 A410075 A413532 A416270

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0641-2018
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)