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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72585

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

Open FDA event record

Event summary

Timeline bucket
October 26, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Merz North America, 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

Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.

Z-0366-2016
Recall number
Z-0366-2016
Initiated
October 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
Merz North America, Inc.
Quantity
1,616 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label is incorrect

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

The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

Code information

Lot No. 100083189

Distribution pattern

Nationwide Distribution including the states of AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, LA, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI.