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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71615

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

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Event summary

Timeline bucket
July 02, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Silhouette Lift, Inc.

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

Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

Z-2208-2015
Recall number
Z-2208-2015
Initiated
July 02, 2015
Classification
Class II
Status
Terminated
Recalling firm
Silhouette Lift, Inc.
Quantity
2,260 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product.

Code information

n/a. This action does not involve recall or correction of any device. Only marketing materials are being considered in this action

Distribution pattern

US Distribution to the states of : CA, TX, IA, MA, RI, GA, WI, PA, VA, MO, FL, NE, MI, NY and CO., and Internationally to Canada.