Z-0401-2021Class II

COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles...

Name: Z-0401-2021 COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles...
Creator: Merz North America, Inc.
Published: 2020-09-30
License: https://open.fda.gov/license/

Merz North America, Inc. / initiated 2020-09-30 / Open, Classified / root cause: labeling and UDI

FDA source

Merz North America, Inc. began a recall of COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calcium hydroxylapatite... on 2020-09-30. FDA classified it as Class II and gives the reason as "The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0401-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-30
Posted: 2020-11-16
Recalling firm: Merz North America, Inc.
Product: 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.
Product code: LNM Agent, Bulking, Injectable For Gastro-Urology Use
Reason for recall: The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Merz NA, in cooperation with Boston Scientific Corporation (BSC) have prepared field action communications including a Medical Device Field Notification Letter and Urgent Medical Device Field Notification Response Form. These letters will be sent via FedEx with delivery confirmation. The units at consignees will not be returned but will be furnished with an updated, revision-controlled IFU.
Quantity in commerce: 2051 units
Distribution: 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
Product codes and lots: Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0401-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0401-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-25	2020-11-16

Product code LNM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)