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U.S. Department of Health and Human Services

Class 2 Device Recall FassierDuval IM Telescopic System

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 Class 2 Recall
FassierDuval IM Telescopic System
see related information
Date Posted April 10, 2014
Recall Status1 Terminated on April 23, 2014
Recall Number Z-1448-2014
Recall Event ID 67675
Premarket Notification
510(K) Numbers
K020885  K041393 
Product Classification Rod, Fixation, Intramedullary And Accessories - Product Code HSB
Product Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
Code Information Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS].
Recalling Firm/
Manufacturer
Pega Medical Inc.
1111 Autoroute Chomedy
Laval
For Additional Information Contact Enrique Garcia
450-688-5144 Ext. 242
Manufacturer Reason
for Recall
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Pega Medical sent an Urgent Field Safety Notice-Recall letter dated February 7, 2014, to their customers via email. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to identify the affected devicee, verify if it was used in a patient and place the affected device in quarantine immediately if not used. If not used, return the affected device to Pega Medical Inc. to the address provided. Pega's customer notification stated "If used, it is recommended to continue the normal patient follow up. Customers with questions should call (450) 688-5144 ext. 242 or email egarcia@pegamedical.com.
Quantity in Commerce Total of 5 units (2 units in the US and 3 units in Germany)
Distribution Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = PEGA MEDICAL INC.
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