Recall Z-0559-2023 · PGN Growing Rod System- Magnetic Actuation
NuVasive Specialized Orthopedics, Inc.
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 9
| Date | Dec 14, 2022 (initiated Nov 1, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On 11/01/2022, the firm sent an URGENT VOLUNTARY MEDICAL DEVICE RECALL Letter via Docusign/FedEx/email to customers (US/OUS Surgeons and Distributors) informing them that the packaging closure integrity (manufactured with an undersized O-ring of the MAGEC 2 (marketed as MAGEC X) packaged units. As a result of the undersized O-ring gland diameter, the O-ring compression is affected when the hard cap if affixed to the packaging tube. The lack of compression can create a situation where the integrity of the container closure system is compromised potentially impacting the sterile barrier system |
| Quantity | 1,873 units |
| Distribution | Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New Zealand, Singapore, Sweden, Thailand, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201543 | MAGEC® System Nuvasive Specialized Orthopedics, Inc., Jul 30, 2020 |