Date Initiated by Firm |
February 07, 2014 |
Date Posted |
April 10, 2014 |
Recall Status1 |
Terminated 3 on April 23, 2014 |
Recall Number |
Z-1448-2014 |
Recall Event ID |
67675 |
510(K)Number |
K020885 K041393
|
Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
|
Product |
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.
|
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]. |
Recalling Firm/ Manufacturer |
Pega Medical Inc. 1111 Autoroute Chomedy Laval Canada
|
For Additional Information Contact |
Enrique Garcia 450-688-5144 Ext. 242
|
Manufacturer Reason for Recall |
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Pega Medical sent an Urgent Field Safety Notice-Recall letter dated February 7, 2014, to their customers via email. The letter identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to identify the affected devicee, verify if it was used in a patient and place the affected device in quarantine immediately if not used. If not used, return the affected device to Pega Medical Inc. to the address provided.
Pega's customer notification stated "If used, it is recommended to continue the normal patient follow up.
Customers with questions should call (450) 688-5144 ext. 242 or email egarcia@pegamedical.com |
Quantity in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = HSB and Original Applicant = PEGA MEDICAL INC.
|