Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC
Medical device recall Z-0790-2019. Published in FDA’s Enforcement Report on Feb 6, 2019.
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 6, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 12 states named in where it went
- 632 units 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?
This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242PC 26mm x 10mm x 12mm PLIF ASSY PC, REF X034-0243PC 26mm x 10mm x 6mm TLIF ASSY PC, REF X034-0280PC 28mm x 10mm x 7mm TLIF ASSY PC, REF X034-0281PC 28mm x 10mm x 8mm TLIF ASSY PC, REF X034-0282PC 28mm x 10mm x 9mm TLIF ASSY PC, REF X034-0283PC 28mm x 10mm x 10mm TLIF ASSY PC, REF X034-0284PC 28mm x 10mm x 11mm TLIF ASSY PC, REF X034-0285PC 28mm x 10mm x 12mm TLIF ASSY PC, REF X034-0286PC 28mm x 10mm x 13mm TLIF ASSY PC, REF X034-0287PC 28mm x 10mm x 14mm TLIF ASSY PC, REF X034-0288PC 28mm x 10mm x 15mm TLIF ASSY PC, REF X034-0289PC 28mm x 10mm x 16mm TLIF ASSY PC, REF X034-0290PC 26mm x 10mm x 6mm 5o PLIF Assy PC, REF X034-0387PC 26mm x 10mm x 7mm 5o PLIF Assy PC, REF X034-0388PC 26mm x 10mm x 8mm 5o PLIF Assy PC, REF X034-0389PC 26mm x 10mm x 9mm 5o PLIF Assy PC, REF X034-0390PC 26mm x 10mm x 10mm 5o PLIF Assy PC, REF X034-0391PC 26mm x 10mm x 11mm 5o PLIF Assy PC, REF X034-0392PC 26mm x 10mm x 12mm 5o PLIF Assy PC, REF X034-0393PC 26mm x 10mm x 13mm 5o PLIF Assy PC, REF X034-0394PC 26mm x 10mm x 14mm 5o PLIF Assy PC, REF X034-0395PC 26mm x 10mm x 15mm 5o PLIF Assy PC, REF X034-0396PC This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
632 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UPC/UDI/Lot numbers REF X034-0172PC, M697X0340172PC1 19211-2, 21017-1 REF X034-0173PC, M697X0340173PC1 041790, 17075-5, 17196-3 REF X034-0240PC, M697X0340240PC1 042050, 18890-1, 20745-1, 17196-12, 18216-1 REF X034-0241PC, M697X0340241PC1…
Every code shown here, 1,991 characters
UPC/UDI/Lot numbers REF X034-0172PC, M697X0340172PC1 19211-2, 21017-1 REF X034-0173PC, M697X0340173PC1 041790, 17075-5, 17196-3 REF X034-0240PC, M697X0340240PC1 042050, 18890-1, 20745-1, 17196-12, 18216-1 REF X034-0241PC, M697X0340241PC1 039171, 042071, 054614, 056529, 057161, 058525, 17196-13, 20745-2 REF X034-0242PC, M697X0340242PC1 20962, 054621, 055442, 058526, 20745-3 REF X034-0243PC, M697X0340243PC1 042073, 054624, 058527, 16730-15, 17075-16, 17196-15,18216-4, 19212-4, 20745-4 REF X034-0280PC, M697X0340280PC1 043764, 062836, 063476, 065284, 040738PC, 19626-1, 19903-1, 20164-1, 20774-1 REF X034-0281PC, M697X0340281PC1 040746PC, 043852, 054531, 055202, 055436, 055742, 056756, 059809, 061983, 062837, 17304-2, 19903-2, 19212-7, 19626-2, 19891-1, 20164-2, 20774-2, 21269-2 REF X034-0282PC, M697X0340282PC1 040757PC, 043765, 054532, 054539, 055203, 055437, 055745, 056757, 059810, 062080, 062838, 063529, 19212-8, 19626-3, 19742-3 19903-1, 19903-3,20164-3, 20774-3, REF X034-0283PC, M697X0340283PC1 040759PC, 043853, 054370, 054540, 055204, 055438, 055746, 056758, 059811, 062081, 062839, 064312, 19212-9, 19626-4, 19742-4, 19903-4, 20462-3, 20774-4, 20164-4, 21269-3 REF X034-0284PC, M697X0340284PC1 040758PC, 043854, 054399, 054541, 055205, 055439, 055747, 056759, 059812, 062082, 19147-8A, 19903-5, 19212-10, 19626-5, 19742-5, 20164-5, 20462-4A REF X034-0285PC, M697X0340285PC1 040761PC, 043855, 054401, 055206, 054542, 055206, 055440, 055748, 056760, 059821, 19147-10, 19626-6, 20164-6 REF X034-0286PC, M697X0340286PC1 055441, 055749, 059822, 040809PC, 17304-7, 19212-12, 19626-7, 19742-7, 19903-7, 20164-7, 20462-5 REF X034-0287PC, M697X0340287PC1 040937PC, 19147-4, 19217-1, 19742-8, 20164-8, 20462-6 REF X034-0288PC, M697X0340288PC1 043856, 040810PC, 19147-5, 19147-5A, 19217-2, 19742-9, 19903-9 REF X034-0289PC, M697X0340289PC1 040938, 040938PC, 19147-6, 19217-3, 19147-6A, 19742-10, 20164-10 REF X034-0290PC, M697X0340290PC1 040745, 043859, 17304-11, 17304-11PC, 18574-7,…
FDA’s list runs to 3,056 characters. The first part is shown; the rest is on FDA’s record.
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.
US Distribution in states of: AZ, CA, CO, FL, IN, LA, MS, GA, KA, MI, NV, WV, TX, and internationally to: Australia, Mexico, Portugal, UK, and Italy.
The states and territories these words name
- Arizona
- California
- Colorado
- Florida
- Georgia
- Indiana
- Louisiana
- Michigan
- Mississippi
- Nevada
- Texas
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Dec 19, 2018.
- FDA classified it on Jan 30, 2019.
- FDA’s Enforcement Report published it on Feb 6, 2019.
- FDA terminated it on Apr 1, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- XTANT MEDICAL INC, of Belgrade, MT.
- 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.”
- FDA’s list of codes runs to 3,056 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.