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U.S. Department of Health and Human Services

Class 2 Device Recall SCFE Drivers of the FreeGliding SCFE Screw System

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  Class 2 Device Recall SCFE Drivers of the FreeGliding SCFE Screw System see related information
Date Initiated by Firm June 15, 2015
Date Posted June 26, 2015
Recall Status1 Terminated 3 on December 29, 2015
Recall Number Z-1848-2015
Recall Event ID 71560
510(K)Number K131591  
Product Classification Screw, fixation, bone - Product Code HWC
Product Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Code Information Part Number: SCF-MLD265, LOT#: 130703-01. Part Number: SCF-MLD273, LOT#: 130703-02.
Recalling Firm/
Pega Medical Inc.
1111 Autoroute Chomedy
Laval Canada
For Additional Information Contact Enrique Garcia
450-688-5144 Ext. 242
Manufacturer Reason
for Recall
SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
FDA Determined
Cause 2
Reprocessing Controls
Action Pega Medical sent an Urgent Field Safety-Recall letter via email on June 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advise on action to be taken by the customer: ¿ Identify the device with the same catalogue number and lot number ¿ Return the device to Pega Medical Inc. to the address shown below using the FedEx account. For further questions please call the firm at 450-688-5144 x. 242.
Quantity in Commerce 4 units
Distribution US Distribution to 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.