Z-0603-2020Class II

Proximal Humerus Plate, 8 holes, Right, REF MDS130108R -

Name: Z-0603-2020 Proximal Humerus Plate, 8 holes, Right, REF MDS130108R -
Creator: Miami Device Solutions, LLC.
Published: 2019-01-15
License: https://open.fda.gov/license/

Miami Device Solutions, LLC / initiated 2019-01-15 / Terminated / root cause: manufacturing process

FDA source

Miami Device Solutions, LLC. began a recall of Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps... on 2019-01-15. FDA classified it as Class II and gives the reason as "Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0603-2020
Classification: Class II
Status: Terminated
Initiated: 2019-01-15
Posted: 2019-12-05
Terminated: 2020-12-11
Recalling firm: Miami Device Solutions, LLC
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
Root cause tag: manufacturing process
FDA 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 in commerce: 15 units
Distribution: US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA.
Product codes and lots: Lot number PM00208

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0603-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0603-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-11	2019-12-05

Product code HRS

K141493Class IIProximal Humerus Plating SystemMiami Device Solutions / cleared 2015-03-20

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)