FDA Device recall Z-1898-2020
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 surg…
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of 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 surg… by Nuvasive, citing 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 compon….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1898-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-13 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Nuvasive |
| Distribution | US |
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
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.
Identifiers
| code_info | Part Number: MC2-4570R Product: MAGEC 2 ROD, 4.5mm 70mmOFFSET Lot Numbers: 8061403AAA 8061411AAA 8061419AAA 806…Part Number: MC2-4570R Product: MAGEC 2 ROD, 4.5mm 70mmOFFSET Lot Numbers: 8061403AAA 8061411AAA 8061419AAA 8061419AAB 8061508AAA 8061808AAA 8061809AAA 8062301AAA 8062602AAA 8062705AAA 8062810AAA 8062810AAB 8063003AAA 8063011AAA 8072409AAA 8072501AAA 8072505AAA 8072627AAA 8072628AAA 8080805AAA 8081102AAA 8092609AAA 8100810AAA 8101905AAA 8102003AAA 8103165AAA 8110306AAA 8111202AAA 8111504AAA 8111508AAA 8122101AAA 8122610AAA 9011102AAA 9011428AAA 9011429AAA 9021601AAA 9021603AAA 9022703AAA 9031511AAA 9031601AAA 9032002AAA 9032901AAA 9032914AAA 9032915AAA 9042508AAA 9042601AAA 9070104AAA 9070112AAA 9071114AAA 9071521AAA 9071610AAA 9071617AAA 9072215AAA 9072701AAA 9072702AAA 9072705AAA 9073001AAA 9073022AAA 9081501AAA 9081502AAA 9082113AAA 9091905AAA 9091906AAA 9112302AAA 9121924AAA 9121938AAA 9121941AAA 9122622AAA Part Number: MC2-4570S Product: MAGEC 2 ROD, 4.5mm 70mmSTANDARD Lot Numbers: 8060727AAA 8061101A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1898-2020%22
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