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Merz North America, Inc. recalls COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns
Recalled November 25, 2020 · FDA recall Z-0401-2021 · Merz North America
Hazard
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study. · FDA Class II
Units
2051 units
Sold at
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
Description
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
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.
Manufacturer(s)
Merz North America, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →