Z-1448-2014Class II

Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number...

Name: Z-1448-2014 Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number...
Creator: Pega Medical Inc.
Published: 2014-02-07
License: https://open.fda.gov/license/

Orthopediatrics Canada ULC / initiated 2014-02-07 / Terminated / root cause: manufacturing process

FDA source

Pega Medical Inc. began a recall of Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS... on 2014-02-07. FDA classified it as Class II and gives the reason as "The Male Components in this lot are made of material with lower strength than manufacturing specifications". 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-1448-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-07
Posted: 2014-04-10
Terminated: 2014-04-23
Recalling firm: Orthopediatrics Canada ULC
Product: Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Pega Medical sent an Urgent Field Safety Notice-Recall letter dated February 7, 2014, to their customers via email. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to identify the affected devicee, verify if it was used in a patient and place the affected device in quarantine immediately if not used. If not used, return the affected device to Pega Medical Inc. to the address provided. Pega's customer notification stated "If used, it is recommended to continue the normal patient follow up. Customers with questions should call (450) 688-5144 ext. 242 or email [email protected]
Quantity in commerce: Total of 5 units (2 units in the US and 3 units in Germany)
Distribution: Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
Product codes and lots: Lot #: 130424-15 (only laser marked on the Part Number: M040-SS-110); Lot #: 121109-11 &130424-15 [Indicated on the label of the Catalogue Number: FD-040(L)-SS].

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1448-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1448-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-10

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)