Allen Medical Bow Frame
Medical device recall Z-0641-2018. Published in FDA’s Enforcement Report on Feb 28, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 28, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 161 units total how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures.
161 units total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 926 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 6, 2017.
- FDA classified it on Feb 20, 2018.
- FDA’s Enforcement Report published it on Feb 28, 2018.
- FDA terminated it on Apr 3, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Allen Medical Systems, of Acton, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.