Z-1546-2015Class II

Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic...

Name: Z-1546-2015 Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic...
Creator: Pega Medical Inc.
Published: 2015-04-10
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2015-04-10 / Terminated / root cause: manufacturing process

FDA source

Pega Medical Inc. began a recall of Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is... on 2015-04-10. FDA classified it as Class II and gives the reason as "The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading...". 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-1546-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-10
Posted: 2015-04-29
Terminated: 2015-06-29
Recalling firm: Orthopediatrics Canada ULC
Product: Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent the Urgent Field Safety Notice-Recall letter, dated April 10, 2015 to consignees via email. The letter listed the affected product as FEMALE DRIVER FASSIER-DUVAL IM TELESCOPIC SYSTEM. Consignees are requested to return devices back to the firm for disposal. Consignees with questions should contact the firm at 450-688-5144 ext. 242 or send email to [email protected]
Quantity in commerce: 9 units (5 units in the US and 4 units international)
Distribution: Worldwide distribution. US in Delaware, Florida, Nebraska, and New York; Australia, Brazil, and United Kingdom.
Product codes and lots: Lot 290609-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1546-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1546-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-29

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)