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.
Recall
- Recall Number
- Z-0603-2020
- Event Number
- 84230
- Firm
- Miami Device Solutions, LLC.
- FEI Number
- 3009222247
- Product Code
- HRS
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 15, 2019
- Terminated
- December 11, 2020
- Address
- 7620 Nw 25th St, Ste 3, Miami, FL, 33122-1719
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.
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
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.
US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA.
15 units