Recall Z-0603-2020 ยท HRS Plate, Fixation, Bone
Miami Device Solutions, LLC.
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 speci
| Date | Jan 15, 2019 |
| Status | Terminated |
| Reason | Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left. |
| Root cause | 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 | 15 units |
| Distribution | US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141493 | PROXIMAL HUMERUS PLATING SYSTEM Miami Device Solutions, Mar 20, 2015 |