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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74252

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

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Event summary

Timeline bucket
May 20, 2016
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, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.

Z-2607-2016
Recall number
Z-2607-2016
Initiated
May 20, 2016
Classification
Class II
Status
Terminated
Recalling firm
Merz North America, Inc.
Quantity
1,591 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.

Code information

Model number: 8063M0K1, Lot #100088744.

Distribution pattern

US Nationwide Distribution in the states of AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT and WA.