Date Initiated by Firm |
February 04, 2015 |
Date Posted |
March 17, 2015 |
Recall Status1 |
Terminated 3 on October 30, 2015 |
Recall Number |
Z-1287-2015 |
Recall Event ID |
70664 |
510(K)Number |
K102795
|
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product |
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia)
The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty. |
Code Information |
Lot# 124471 |
Recalling Firm/ Manufacturer |
Materialise N.V. 15 Technologielaan Heverlee Belgium
|
For Additional Information Contact |
Noortje Merckx 321-639-6611
|
Manufacturer Reason for Recall |
Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
|
FDA Determined Cause 2 |
Employee error |
Action |
Materialise N.V. sent an email on February 4, 2015, to the the affected distributor regarding the reason for the recall, affected product, and instructions for removing the affected product. For questions regarding this recall call 321-639-6611. |
Quantity in Commerce |
1 unit |
Distribution |
Worldwide Distribution to the Netherlands only. |
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 = JWH and Original Applicant = MATERIALISE N.V.
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