Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of

FDA device recall Z-1494-2011 · posted 2011-03-02 · Terminated

Recall details

Recalling firm

Pega Medical Inc.

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.

Action taken

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

Status

Terminated

Product code

HSB

Quantity affected

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.

Date initiated

2010-01-29

Date posted

2011-03-02

Date terminated

2011-03-26

Location

Laval, Canada

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