Z-1657-2025 Class II Ongoing
FDA device recall Z-1657-2025 was initiated by Globus Medical, Inc. on April 3, 2025 and is designated Class II. Reason for recall: Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm. The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- April 30, 2025
- Initiation Date
- April 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Reason for Recall
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
Distribution Pattern
US Nationwide distribution in the state of AR.
Code Information
Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET