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Terminated

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.

FDA Recall Z-0603-2020 · Posted None

Recalling FirmMiami Device Solutions, LLC.
Recall StatusTerminated
Product CodeHRS
Date Initiated2019-01-15
Date Terminated2020-12-11
Product Quantity15 units

Reason for Recall

Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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