| Class 2 Device Recall Proximal Humerus Plate, 8 holes, Right | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HRS
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