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U.S. Department of Health and Human Services

Class 2 Device Recall MEDICREA INTERNATIONAL

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  Class 2 Device Recall MEDICREA INTERNATIONAL see related information
Date Initiated by Firm September 16, 2019
Create Date January 24, 2020
Recall Status1 Open3, Classified
Recall Number Z-0828-2020
Recall Event ID 84595
510(K)Number K190376  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol
Product reference: A06010140
Code Information Lot number(s) : 18G0368; 19H0009; 18F0138; 18G0038
Recalling Firm/
Manufacturer		 Medicrea International
5389 Route De Strasbourg
Vancia
Rillieux La Pape France
Manufacturer Reason
for Recall		 Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
FDA Determined
Cause 2		 Process control
Action Medicrea International issued letter dated 9/12/19 to US Distributor stating reason for recall, health risk and action to take: 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 organisations. Please inform MEDICREA of any adverse events concerning the use of the subject devices 2. Please comply with any local laws or regulations concerning the notification of adverseevents to your National Competent Authority. 3. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Contact: 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 190 units
Distribution Nationwide
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 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) Database 510(K)s with Product Code = KWP and Original Applicant = Medicrea International S.A.
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