medical Class II Updated 2020-11-25

Merz North America, Inc. recalls COAPTITE Injectable Implant, injectable, sterile, non-pyroge

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Affected States: 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

Lot/Code Info: Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615

View official government recall

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