Z-1494-2011

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

Name: Z-1494-2011 Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the...
Creator: Pega Medical Inc.
Published: 2010-01-29
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2010-01-29 / Terminated / root cause: manufacturing process

FDA source

Pega Medical Inc. began a recall of 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... on 2010-01-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1494-2011
Status: Terminated
Initiated: 2010-01-29
Posted: 2011-03-02
Terminated: 2011-03-26
Recalling firm: Orthopediatrics Canada ULC
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.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Catalog number MDr132L (size 3.2 mm) with Lot Code 270730-01. Catalog number MDr140L (size 4.0 mm) with Lot Code 270730-02.

Product code HSB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)