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U.S. Department of Health and Human Services

Class 2 Device Recall Proximal Humerus Plate, 8 holes, Right

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  Class 2 Device Recall Proximal Humerus Plate, 8 holes, Right see related information
Date Initiated by Firm January 15, 2019
Create Date December 05, 2019
Recall Status1 Terminated 3 on December 11, 2020
Recall Number Z-0603-2020
Recall Event ID 84230
510(K)Number K141493  
Product Classification Plate, fixation, bone - Product Code HRS
Product Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.
Code Information Lot number PM00208
Recalling Firm/
Manufacturer
Miami Device Solutions, LLC.
7620 Nw 25th St Ste 3
Miami FL 33122-1719
For Additional Information Contact Larry Dominguez
786-422-1400
Manufacturer Reason
for Recall
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
FDA Determined
Cause 2
Process control
Action The firm notified their consignees by email beginning on 01/15/2019 requesting the examination of the Proximal Humerus Plates for mismarked units. Return of the units is ongoing.
Quantity in Commerce 15 units
Distribution US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, 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 = HRS and Original Applicant = Miami Device Solutions
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