Exact FDA event identifier

Event 76868

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

Open FDA event record

Event summary

Timeline bucket: March 27, 2017
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

Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

Z-2070-2017

Recall number: Z-2070-2017
Initiated: March 27, 2017
Classification: Class II
Status: Terminated
Recalling firm: Mentor Texas, LP.
Quantity: 28 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Missing Dome Pack accessory.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Missing Dome Pack accessory.

Code information

Lot Number: 7377332

Distribution pattern

US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.