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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 3.5 MM LCP(R) Distal Humerus System

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 Class 2 Recall
Synthes 3.5 MM LCP(R) Distal Humerus System
see related information
Date Posted September 25, 2013
Recall Status1 Open
Recall Number Z-2278-2013
Recall Event ID 65009
Premarket Notification
510(K) Number
K033995 
Product Classification Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Product Code KTT
Product Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
Code Information Part Number 241.267, lot number 8037923
Recalling Firm/
Manufacturer
Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Synthes Customer Service
610-719-5000
Manufacturer Reason
for Recall
Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Synthes sent an Urgent Notice Medical Device Recall letter dated March 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to obtain a Return Authorization Number, complete the Verification Section at the end of the letter by the checking the appropriate box indicating affected product located. Return the Verification Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. Customers with questions were instructed to call 610-719-5450 or email Fieldaction@synthes.com. For questions regarding this recall call 610-719-5000.
Quantity in Commerce 2
Distribution Nationwide Distribution including CA,and VA. .
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = SYNTHES (USA)
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