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U.S. Department of Health and Human Services

Class 2 Device Recall MAGEC

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 Class 2 Device Recall MAGECsee related information
Date Initiated by FirmApril 03, 2025
Date PostedApril 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1657-2025
Recall Event ID 96615
510(K)NumberK171791 
Product Classification Growing rod system- magnetic actuation - Product Code PGN
ProductMAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Code Information Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
Recalling Firm/
Manufacturer		 Globus Medical, Inc.
2560 General Armistead Ave
West Norriton PA 19403-5214
For Additional Information ContactMr. Daniel S. Paul
610-930-1800
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 in Commerce1 unit
DistributionUS Nationwide distribution in the state of AR.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PGN
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