Food, drugs, devices › Pega Medical Inc.
Device recall: Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in I
Pega Medical Inc. (Laval, N/A) initiated this device recall on 7 Feb 2014; FDA lists 1 product record under event 67675, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 23 Apr 2014. Initiation: voluntary: firm initiated. Pega Medical Inc. has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Pega Medical Inc., Laval, N/A, Canada.
Reason for recall
"The Male Components in this lot are made of material with lower strength than manufacturing specifications."
Distribution
"Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1448-2014 | 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. | Total of 5 units (2 units in the US and 3 units in Germany) | Class II | Terminated | 16 Apr 2014 |
Context
Other enforcement events for Pega Medical Inc.
All 9 events for Pega Medical Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The Male Components in this lot are made of material with lower strength than manufacturing specifications."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Apr 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.