Class 2 Device Recall FassierDuval Telescopic IM System

• Date Initiated by Firm: January 29, 2010
• Date Posted: March 02, 2011
• Recall Status: Terminated on March 26, 2011
• Recall Number: Z-1494-2011
• Recall Event ID: 54620
• 510(K)Number: K020885 K041393
• Product Classification: orthopedic manual instrument - Product Code HSB
• Product: Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation.
• Code Information: Catalog number MDr132L (size 3.2 mm) with Lot Code 270730-01. Catalog number MDr140L (size 4.0 mm) with Lot Code 270730-02.
• Recalling Firm/ Manufacturer: Pega Medical Inc.; 1105 Autoroute Chomedy; Laval Canada
• For Additional Information Contact: 450-688-5144
• Manufacturer Reason for Recall: Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component.
• FDA Determined Cause: Process control
• Action: On 01/29/2010, Pega Medical began contacting their consignees by e-mail and telephone. Pega Medical followed up with their consignees by sending out the replacement components along with the explanation letter. The subject on the letter is Notice for 3.2 mm and 4.0 mm Male Drivers of the Fassier-Duval IM Telescopic System. The consignees were informed that there could be a structural weakness in some of the Male Driver instruments. This problem has been detected on the 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component. Consignees can contact Pega Medical at 450-688-5144 x 242.
• Quantity in Commerce: 4 units of MDr132L (3.2 mm) and 3 units of MDr140 (4.0 mm) distributed in US.
• Distribution: Components were distributed to four hospitals in the US in the state of GA, OK, TN, and UT.
• 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