FDA Medical Device Recalls (openFDA)
Globus Medical, Inc.: MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
- Recall number
- Z-1657-2025
- Recalling firm
- Globus Medical, Inc.
- Product
- MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
- Status
- Open, Classified
- Initiated
- 2025-04-03
- Posted
- 2025-04-23
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On April 3, 2025, URGENT: MEDICAL DEVICE NOTIFICATION letter was sent to their customer. Actions to be taken by Customers/Users The customer is instructed to monitor their patient closely for any potential adverse events. Report any adverse events believed to be associated with this notification to Globus Medical. In addition, any adverse events associated with the use of this product and/or quality problems should also be reported to the FDA's MedWatch Program: MedWatch: The FDA Safety Information and Adverse Event Reporting Program; For Questions and Support: Globus Medical Complaint Handling Unit: Email: recall@globusmedical.com Globus Medical is committed to serving your product needs and our primary objectives are patient safety, exceptional product reliability, and the highest level of customer satisfaction. Thank you for your prompt support on this important matter. We appreciate your cooperation.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of AR.
- Lot, serial or model codes
- Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
- 510(k) numbers
- ["K171791"]
- PMA numbers
- not on file
- Product code
- PGN
- Firm FEI
- 3004142400
- Firm city
- West Norriton
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28