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.
FDA Recall Z-1494-2011 · Posted 2011-03-02
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Recalling FirmPega Medical Inc.
Recall StatusTerminated
Product CodeHSB
Date Initiated2010-01-29
Date Terminated2011-03-26
Product Quantity4 units of MDr132L (3.2 mm) and 3 units of MDr140 (4.0 mm) distributed in US.
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Components were distributed to four hospitals in the US in the state of GA, OK, TN, and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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