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U.S. Department of Health and Human Services

Class 2 Device Recall 4.5mm TI Multiloc Screw Length 38MM

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  Class 2 Device Recall 4.5mm TI Multiloc Screw Length 38MM see related information
Date Initiated by Firm May 22, 2012
Date Posted July 23, 2012
Recall Status1 Terminated 3 on September 10, 2015
Recall Number Z-2059-2012
Recall Event ID 62307
510(K)Number K103002  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product 4.5mm TI Multiloc Screw Length 38MM-Sterile
Expiration: 04/29/2012
REF 04.019.038S

Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132

4.5MM TI Multiloc Screw Length 38MM-Sterile
Ref 04.019,038S.

The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).
Code Information Lot #2724103 Expiration 4/29/2012 REF 04.019.038S 
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
FDA Determined
Cause 2		 Error in labeling
Action Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated May 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return via fax to 610-251-9005. Contact the firm at 610-719-5450 for questions regarding this recall.
Quantity in Commerce 20
Distribution Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.
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 = HSB and Original Applicant = SYNTHES (USA)
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