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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84230

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 15, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Miami Device Solutions, LLC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0603-2020
Recall number
Z-0603-2020
Initiated
January 15, 2019
Classification
Class II
Status
Terminated
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot number PM00208

Distribution pattern

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