Z-0603-2020 Class II Terminated
FDA device recall Z-0603-2020 was initiated by Miami Device Solutions, LLC. on January 15, 2019 and is designated Class II. Reason for recall: Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left. The recall status is terminated (terminated December 11, 2020). Affected quantity: 15 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2019
- Initiation Date
- January 15, 2019
- Termination Date
- December 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Product Description
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.
Reason for Recall
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
Distribution Pattern
US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA.
Code Information
Lot number PM00208