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U.S. Department of Health and Human Services

Class 2 Device Recall Medicrea International Universal Counter Torque

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  Class 2 Device Recall Medicrea International Universal Counter Torque see related information
Date Initiated by Firm November 11, 2019
Create Date March 02, 2020
Recall Status1 Terminated 3 on October 14, 2020
Recall Number Z-1234-2020
Recall Event ID 84765
510(K)Number K190376  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System
Ref : A22020500
Code Information Lot Number:19H0108 Exp.Date: 19/08/2029
Recalling Firm/
Manufacturer		 Medicrea International
5389 Route De Strasbourg
Vancia
Rillieux La Pape France
For Additional Information Contact SAME
646-4902360 Ext. 2426
Manufacturer Reason
for Recall		 Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
FDA Determined
Cause 2		 Device Design
Action Medicrea issued notification dated 11/11/19 via email, stating reason for recall, health risk and action to take: 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA. 2. Circulate this Field Safety Notice internally to all interested/affected parties. 3. Inform MEDICREA if any of the subject devices have been distributed to other organizations. inform MEDICREA of any adverse events concerning the use of the subject devices. Complete the attached customer response form. contact person for this action is given below: Karine TROGNEUX-MEDICREA INTERNATIONAL Regulatory Affairs Manager Direct : +33(0)4.69.85.95.39 Standard : +33 (0)4.72.01.87.87. Fax - N¿ +33 (0)04 72 01 87 88 Mail : ktrogneux@medicrea.com
Quantity in Commerce 3 units
Distribution CA, FL
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = Medicrea International S.A.
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