Allen Medical Systems Radiolucent Surgery Spine Frame Recall: Base Cracking Risk
Allen Medical Systems recalls Radiolucent Surgery Spine Frame (F70801) due to potential base cracking when transferring patients. This could lead to instability during lumbar spine procedures. Affected units have specific serial numbers.
Use caution until it’s fixed
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Contact the company
What happened, in plain English
Allen Medical Systems is recalling their Radiolucent Surgery Spine Frame (F70801) because the base might crack when moving patients onto the frame. This could cause instability during lumbar spine surgeries, potentially leading to injury. Read more at govinfonow.com/recall/72885-allen-medical-systems-radiolucent-surgery-spine-frame-recall-base-cracking.
Source Summary by GovInfoNow · govinfonow.com/recall/72885-allen-medical-systems-radiolucent-surgery-spine-frame-recall-base-cracking · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0642-2018
Cite this page
“Allen Medical Systems Radiolucent Surgery Spine Frame Recall: Base Cracking Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72885-allen-medical-systems-radiolucent-surgery-spine-frame-recall-base-cracking. Based on FDA recall #Z-0642-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0642-2018%22&limit=1).
Why it’s dangerous
The frame's base can crack when a patient is first moved onto the frame. This cracking could cause the frame to become unstable during surgery, potentially leading to injury.
Who’s affected
Surgical teams using the Radiolucent Surgery Spine Frame for lumbar spine procedures are most at risk. Patients undergoing these procedures may be affected if the frame cracks during transfer.
How to tell if you have this one
Check for the model number F70801 on the frame. Affected units have specific serial numbers: 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.
- Brand
Allen Medical Systems- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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.
| Recall number | Product, codes & lots |
|---|---|
| Z-0641-2018 | Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.; 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 |
| Z-0642-2018 | Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.; 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 |
What to do — step by step
Check Frame Serial Number
Look for the serial numbers listed in the recall notice to confirm if your frame is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0642-2018 (October 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0642-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.