Recall Z-0603-2020— Miami Device Solutions, LLC.

Name: FDA recall Z-0603-2020
Creator: U.S. Food and Drug Administration
Published: 2019-01-15

Class II · Terminated

Class II FDA medical device recall by Miami Device Solutions, LLC., initiated 2019-01-15, terminated 2020-12-11. It names one FDA 510(k) clearance: K141493. 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.. Reason: Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left..

Recalling firm: Miami Device Solutions, LLC.
Classification: Class II
Status: Terminated
Initiated: 2019-01-15
Terminated: 2020-12-11
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K141493 — PROXIMAL HUMERUS PLATING SYSTEMMiami Device Solutions·cleared 2015-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.