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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69022

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

Open FDA event record

Event summary

Timeline bucket
July 02, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mentor Texas, LP.

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

EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.

Z-2591-2014
Recall number
Z-2591-2014
Initiated
July 02, 2014
Classification
Class II
Status
Terminated
Recalling firm
Mentor Texas, LP.
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The device labeling is stamped with 330cc and the device is actually 380cc device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device labeling is stamped with 330cc and the device is actually 380cc device.

Code information

Part Number (PN) 351-3380SZ Lot Number 6830722

Distribution pattern

U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.