Date Initiated by Firm |
April 27, 2021 |
Create Date |
June 04, 2021 |
Recall Status1 |
Completed |
Recall Number |
Z-1797-2021 |
Recall Event ID |
87842 |
Product Classification |
System, facet screw spinal device - Product Code MRW
|
Product |
Braive 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 |
Recalling Firm/ Manufacturer |
Medtronic Sofamor Danek USA, Inc 4340 Swinnea Rd Memphis TN 38118-6603
|
For Additional Information Contact |
Victor 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 |
Action |
On 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 Commerce |
162 UNITS |
Distribution |
International distribution in the countries of France, Switzerland and Jordan. No US distribution. |
Total Product Life Cycle |
TPLC Device Report
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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.
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