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U.S. Department of Health and Human Services

Enforcement Report - Week of April 16, 2014

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Product Detail

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.
Recall Number Z-1448-2014
Classification Class II
Code Info 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].
Product Distributed Qty Total of 5 units (2 units in the US and 3 units in Germany)
Reason For Recall The Male Components in this lot are made of material with lower strength than manufacturing specifications.

Event Detail

Event Id 67675
Product Type Devices
Status Ongoing
Recalling Firm Pega Medical Inc.
City Laval
Country CA
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-07
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.