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U.S. Department of Health and Human Services

Class 2 Device Recall Braive Growth Modulation System BreakOff Set Screws

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 Class 2 Device Recall Braive Growth Modulation System BreakOff Set Screwssee related information
Date Initiated by FirmApril 27, 2021
Create DateJune 04, 2021
Recall Status1 Terminated 3 on August 20, 2024
Recall NumberZ-1797-2021
Recall Event ID 87842
Product Classification System, facet screw spinal device - Product Code MRW
ProductBraive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.
Code Information CT20L012 and CT20L020.  CT20L012 EXP 2 DEC 2028 CT20L020 EXP 11 DEC 2028
FEI Number 3003120897
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA, Inc
4340 Swinnea Rd
Memphis TN 38118-6603
For Additional Information ContactVictor Rocha
901-396-3133
Manufacturer Reason
for Recall		Product is impacted by a thread profile defect due to a manufacturing issue.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 4/26/2021 the firm sent a letter to its consignees with the following instructions: Required Actions: 1) Identify, segregate, and quarantine any impacted product (listed above) within your inventory. 2) Return the impacted product to Medtronic. Your Medtronic Sales Representative can assist in facilitating the return of product as necessary. 3) Please maintain a copy of this notice in your records. 4) Please share this communication within your organization, with other organizations where affected devices have been transferred, and any other associated organizations that may be impacted by this action.
Quantity in Commerce162 UNITS
DistributionInternational distribution in the countries of France, Switzerland and Jordan. No US distribution.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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