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.
Reported: April 16, 2014 Initiated: February 7, 2014 #Z-1448-2014
Product Description
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.
Reason for Recall
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Details
- Recalling Firm
- Pega Medical Inc.
- Units Affected
- 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.
- Location
- Laval, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pega Medical Inc.. Units affected: Total of 5 units (2 units in the US and 3 units in Germany).
Why was this product recalled? ▼
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2014. Severity: Moderate. Recall number: Z-1448-2014.
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