Z-1448-2014 Class II Terminated
FDA device recall Z-1448-2014 was initiated by Pega Medical Inc. on February 7, 2014 and is designated Class II. Reason for recall: The Male Components in this lot are made of material with lower strength than manufacturing specifications. The recall status is terminated (terminated April 23, 2014). Affected quantity: Total of 5 units (2 units in the US and 3 units in Germany).
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2014
- Initiation Date
- February 7, 2014
- Termination Date
- April 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total of 5 units (2 units in the US and 3 units in Germany)
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.
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
Code Information
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].