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U.S. Department of Health and Human Services

Class 2 Device Recall Materialise Distributed by Biomet Orthopedics, Signature Personalized Patient Care System

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 Class 2 Device Recall Materialise Distributed by Biomet Orthopedics, Signature Personalized Patient Care Systemsee related information
Date Initiated by FirmFebruary 04, 2015
Date PostedMarch 17, 2015
Recall Status1 Terminated 3 on October 30, 2015
Recall NumberZ-1287-2015
Recall Event ID 70664
510(K)NumberK102795 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductSignature 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
FEI Number 3003998208
Recalling Firm/
Manufacturer		 Materialise N.V.
15 Technologielaan
Heverlee Belgium
For Additional Information ContactNoortje 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
ActionMaterialise 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 Commerce1 unit
DistributionWorldwide Distribution to the Netherlands only.
Total Product Life CycleTPLC Device Report
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) Database510(K)s with Product Code = JWH
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