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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86572

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

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Event summary

Timeline bucket
September 30, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite (CaHA), suspended in aqueous based gel carrier. Gel carrier is composed of sodium carboxymethylcellulose, sterile water for injection, and glycerin. Product is packaged in a 1.0cc syringe and packed in a sterile pouch.

Z-0401-2021
Recall number
Z-0401-2021
Initiated
September 30, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Merz North America, Inc.
Quantity
2051 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.

Code information

Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615

Distribution pattern

US only distribution - AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV