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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72168

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

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Event summary

Timeline bucket
August 21, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DJO, 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

Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.

Z-0121-2016
Recall number
Z-0121-2016
Initiated
August 21, 2015
Classification
Class II
Status
Terminated
Recalling firm
DJO, LLC
Quantity
2887

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Overheating and burning of the wire insulation inside the applicator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Overheating and burning of the wire insulation inside the applicator.

Code information

Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015

Distribution pattern

Worldwide Distribution - US Nationwide in the states of WY, OH, WA, NC, FL, NE, GA, KS CA, MO, IN, MA, IL, OK, AZ, TX, AR, UT, NJ, WI, PA, SC, WV, NY, MI, MN, VA, AK, TN, OR, NC, NH, KY, CO, NV, ID and the countries of El Salvador, China, Ecuador, South Korea, Chile, Israel, Peru, Nicaragua, Bolivia, Indonesia