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.
Recall
- Recall Number
- Z-1494-2011
- Event Number
- 54620
- Firm
- Pega Medical Inc. 1105 Autoroute Chomedy Laval Canada
- FEI Number
- 3000327445
- Product Code
- HSB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 29, 2010
- Posted
- March 2, 2011
- Terminated
- March 26, 2011
Description
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.
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.
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.
Components were distributed to four hospitals in the US in the state of GA, OK, TN, and UT.
4 units of MDr132L (3.2 mm) and 3 units of MDr140 (4.0 mm) distributed in US.