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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 Device Recall FassierDuval IM Telescopic System see related information
Date Initiated by Firm April 10, 2015
Date Posted April 29, 2015
Recall Status1 Terminated 3 on June 29, 2015
Recall Number Z-1546-2015
Recall Event ID 71061
510(K)Number K020885  K041393  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures.

This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.
Code Information Lot 290609-01
Recalling Firm/
Manufacturer		 Pega Medical Inc.
1111 Autoroute Chomedy
Laval Canada
For Additional Information Contact Enrique Garcia
450-688-5144
Manufacturer Reason
for Recall		 The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm sent the Urgent Field Safety Notice-Recall letter, dated April 10, 2015 to consignees via email. The letter listed the affected product as FEMALE DRIVER FASSIER-DUVAL IM TELESCOPIC SYSTEM. Consignees are requested to return devices back to the firm for disposal. Consignees with questions should contact the firm at 450-688-5144 ext. 242 or send email to egarcia@pegamedical.com
Quantity in Commerce 9 units (5 units in the US and 4 units international)
Distribution Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.
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 = HSB and Original Applicant = PEGA MEDICAL INC.
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