NUVASIVE MAGEC 2 Rod X — Class II medical device recall Z-1898-2020
Terminated recall by NuVasive Inc, reported 2020-05-13, distributed nationwide. Post-implantation separation of an actuator end cap component that may expose internal components of the actua
| Recall number | Z-1898-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NuVasive Inc, San Diego, CA, United States |
| Recall initiated | 2020-02-13 |
| Classified | 2020-05-05 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2022-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BG, CA, CH, CL, DE, DK, ES, FI, FR, GB, HK, HU, IE, IL, IN, IT, JO, KW, LU, MY, NL, NO, PH, PL, PT, RS, SA, SE, SI, TH, TR, ZA |
| Quantity | 3,502 rods |
| Lot numbers | 0000000AAA, 0010301AAA, 0010333AAA, 0010334AAA, 0010335AAA, 0010336AAA, 0010401AAA, 0010402AAA, 0010403AAA, 0010404AAA, 0010620AAA, 0010621AAA, 0010742AAA, 0010743AAA, 0010770AAA, 0010771AAA, 0010773AAA, 0010818AAA, 0011023AAA, 0011317AAA, 0011318AAA, 0011319AAA, 0011401AAA, 0011402AAA, 0011506AAA, 0011524AAA, 0011525AAA, 0011601AAA, 0011602AAA, 0011643AAA, 0011644AAA, 0011714AAA, 0011715AAA, 0011803AAA, 0011804AAA, 0012003AAA, 0012020AAA, 0012024AAA, 0012101AAA, 0012102AAA and 460 more |
| Model numbers | MC2-4570R, MC2-4570S, MC2-4590R, MC2-4590S, MC2-5070R, MC2-5070S, MC2-5090R, MC2-5090S, MC2-5570R, MC2-5570S, MC2-5590R, MC2-5590S, MC2-6070R, MC2-6070S, MC2-6090R, MC2-6090S, MC2-XXXXS |
Product
NUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage: comprised of a sterile single-use spinal rod that is surgically implanted using appropriate NuVasive Reline, Reline Small Stature, and Armada fixation components (i.e. Pedicle screws, hooks and/or connectors, provided non-sterile, to be sterilized by the end user).
Reason for recall
Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localized tissue discoloration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1898-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.