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U.S. Department of Health and Human Services

Class 2 Device Recall SCFE Driver

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  Class 2 Device Recall SCFE Driver see related information
Date Initiated by Firm October 20, 2015
Date Posted November 20, 2015
Recall Status1 Terminated 3 on August 16, 2016
Recall Number Z-0324-2016
Recall Event ID 72529
510(K)Number K131591  
Product Classification Screw, fixation, bone - Product Code HWC
Product SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System.

This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number.

The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
Code Information Part Number: SCF-MLD265; LOT#: 130703-01 Part Number: SCF-MLD273; LOT#: 130703-02
Recalling Firm/
Manufacturer		 Pega Medical Inc.
1111 Autoroute Chomedy
Laval Canada
For Additional Information Contact Enrique Garcia
450-688-5144 Ext. 242
Manufacturer Reason
for Recall		 SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action The firm sent the Urgent Field Safety Notice-Recalls to US consignees via email. Consignees are advised to return affected devices back to the firm. Customer with questions can contact Enrique Garcia at 450-688-5144 ext. 242 or send email to egarcia@pegamedical.com
Quantity in Commerce 4 units distributed in the US
Distribution Distributed in the states of FL and TN.
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 = HWC and Original Applicant = PEGA MEDICAL INC.
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