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U.S. Department of Health and Human Services

Class 2 Device Recall NK Flex Pin Guides

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  Class 2 Device Recall NK Flex Pin Guides see related information
Date Initiated by Firm March 23, 2012
Date Posted May 14, 2012
Recall Status1 Terminated 3 on January 23, 2013
Recall Number Z-1544-2012
Recall Event ID 61699
510(K)Number K111492  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product PATIENT SPECIFIC INSTRUMENTS
N-K FLEX PIN GUIDES (FEMUR AND TIBIA)
NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE
Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI
Distributed by Zimmer, Warsaw IN.

Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
Code Information Lot 56529886, REF 005970-000-03 Exp 2012-09-08
Recalling Firm/
Manufacturer		 Materialise USA LLC
44650 Helm Ct
Plymouth MI 48170-6061
For Additional Information Contact Andrea Hook
734-662-5057
Manufacturer Reason
for Recall		 March 23, 2012 a field representative reported patient specific --0242 L tibia guide case packaging contained a different patient specific ..-0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user.
FDA Determined
Cause 2		 Labeling mix-ups
Action Materialise telephoned both field representatives on March 23, 2012 and confirmed recalled product mix-up. Materialise requested both cases be returned and replacements were provided. No affected product was received by the end user.
Quantity in Commerce 1 unit
Distribution Nationwide Distribution including the states of Ohio and Minnesota.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JWH and Original Applicant = MATERIALISE N.V.
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