Severity
Moderate
FDA Devices recall · Reported April 30, 2014
The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.
Pega Medical Inc. recalled Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue nu… - a moderate-severity action.
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue nu… was recalled by Pega Medical Inc. in April 30, 2014. Reason: The outer package label contained the incorrect length of the device. There is a label on the outer package a…. Check the official notice for the remedy. Verify recall #Z-1472-2014 with the FDA Devices before acting.
The recall
Pega Medical Inc. issued this moderate-severity FDA Devices recall-The outer package label contained the incorrect length of the device. There is a label on the outer package a….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1472-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1472-2014) was formally reported on April 30, 2014, with the manufacturer initiating the action on March 5, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Pega Medical Inc. is listed as the recalling firm, operating out of Laval, N/A. Federal records list the affected scope as 48.
The documented reason for this recall is: The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package. Distribution data in the federal record shows the product reached: Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
48
Related Recalls
6
3 from same agency
Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System.
The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1472-2014 |
| Date reported | April 30, 2014 |
| Date initiated | March 5, 2014 |
| Recalling firm | Pega Medical Inc. |
| Firm location | Laval, N/A |
| Affected scope | 48 |
| Distribution | Worldwide distribution, USA nationwide, Greece, United Arab Emirates, Peru, Canada, Israel, United Kingdom, France, Germany, Colombia, Mexico, Singapore, Lithuania, Denmark, and Spain. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 30, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.