NUVASIVE MAGEC MAGEC 2 Rod
Medical device recall Z-0559-2023. Published in FDA’s Enforcement Report on Dec 21, 2022.
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 Dec 21, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 1,873 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?
During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard MC2-6090R / PA0684-003 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-4590R / PA0684-004 / MAGEC 2 Rod, 4.5mm 90mm Offset MC2-5590R / PA0684-005 / MAGEC 2 Rod, 5.5mm 90mm Offset MC2-6090S / PA0684-006 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570S / PA0684-007 / MAGEC 2 Rod, 4.5mm 70mm Standard MC2-5570S / PA0684-008 / MAGEC 2 Rod, 5.5mm 70mm Standard MC2-6070S / PA0684-009 / MAGEC 2 Rod, 6.0mm 70mm Standard MC2-4570R / PA0684-010 / MAGEC 2 Rod, 4.5mm 70mm Offset MC2-5570R / PA0684-011 / MAGEC 2 Rod, 5.5mm 70mm Offset MC2-6070R / PA0864-012 / MAGEC 2 Rod, 6.0mm 70mm Offset MC2-5090S / PA0684-013 / MAGEC 2 Rod, 5.0mm 90mm Standard MC2-5090R / PA0684-014 / MAGEC 2 Rod, 5.0mm 90mm Offset MC2-5070S / PA0684-015 / MAGEC 2 Rod, 5.0mm 70mm Standard MC2-5070R / PA0684-016 / MAGEC 2 Rod, 5.0mm 70mm Offset
1,873 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
REF Model Numbers/NSO Item #/Product Description/UDI-DI Code: MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard / 812258022624 Lot Numbers: 0013101BAB 2091504AAA 8091013BAB 8121214BAD 9031814BAB 9061902BAB 2082304AAA 8060409BAB…
Every code shown here, 1,995 characters
REF Model Numbers/NSO Item #/Product Description/UDI-DI Code: MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard / 812258022624 Lot Numbers: 0013101BAB 2091504AAA 8091013BAB 8121214BAD 9031814BAB 9061902BAB 2082304AAA 8060409BAB 8092007BAB 8121312BAB 9032005BAB 9061911BAB 2082306AAA 8060601BAB 8092102BAB 8121406BAB 9032006BAB 9061912BAB 2082309AAA 8061921BAB 8092404BAB 8121406BAC 9032006BAC 9061912BAC 2082412AAA 8070615BAB 8100410BAB 9010806BAB 9032007BAB 9062018BAB 2091201AAA 8070902BAB 8100410BAC 9011803BAB 9032007BAC 9062411BAB 2091202AAA 8071213BAB 8111306BAB 9011803BAC 9032014BAB 9062412BAB 2091211AAA 8071706BAB 8111415BAB 9020405BAB 9032101BAB 9062412BAC 2091212AAA 8072105BAB 8121109BAB 9021216BAB 9032102BAB 9062413BAB 2091303AAA 8082313BAB 8121109BAC 9021302BAB 9051011BAC 9062508BAB 2091304AAA 8082401BAB 8121111BAB 9021306BAB 9051016BAB 9062517BAB 2091312AAA 8082410BAB 8121205BAB 9022204BAB 9051016BAC 9062519BAB 2091314AAA 8082701BAB 8121211BAB 9022204BAC 9061812BAB 9062520BAB 2091403AAA 8082814BAB 8121214BAB 9022204BAD 9061819BAB 9062702BAB 2091405AAA 8090709BAB 8121214BAC 9031107BAB 9061901BAB 9072313BAB 9072314BAB 9081307BAB 9090931BAC 9091002BAB 9121635BAB 9121719BAB 9072516BAB 9081312BAB 9090956BAB 9093010BAB 9121711BAB 9072601BAB 9090930BAB 9090956BAC 9111222BAB 9121712BAB 9080301BAB 9090931BAB 9091001BAB 9112013BAB 9121713BAB MC2-5590S / PA0684-002 / MAGEC 2 Rod, 5.5,mm 90mm Standard / 812258022662 Lot Numbers: 0010620BAB 8070512BAB 9071302BAB 9090410BAC 8121801BAC 9032222BAB 0010620BAC 8080401BAB 9071302BAC 9091714BAB 8121802BAB 9041701BAB 0010621BAB 8080612BAB 9071517BAB 9091714BAC 9012309BAB 9041706BAB 0013113BAB 8080812BAB 9072315BAB 9091801BAB 9012309BAC 9041707BAB 0013113BAC 8081703BAB 9072318BAB 9111301BAB 9012332BAB 9050704BAB 0013113BAD 8091103BAB 9072319BAB 9111302BAB 9012404BAB 9050706BAB 1041203AAA 8092107BAB 9072415BAB 9111302BAC 9012404BAC 9050712BAB 1041204AAA 8092405BAB 9072415BAC 9111306BAB 9012410BAB 9050806BAB 1050405AAA…
FDA’s list runs to 16,653 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.
Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates.
The states and territories these words name
- Puerto Rico
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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Nov 1, 2022.
- FDA classified it on Dec 14, 2022.
- FDA’s Enforcement Report published it on Dec 21, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- NuVasive Specialized Orthopedics, Inc., of Aliso Viejo, CA.
- 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 16,653 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.