Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
COAPTITE Injectable Implant Recalled by Merz North America, Inc. Due to The Instructions for Use (IFU) updated 03/02/2020 does...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merz North America, Inc. directly.
Affected Products
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.
Quantity: 2051 units
Why Was This Recalled?
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Where Was This Sold?
This product was distributed to 48 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, DC
About Merz North America, Inc.
Merz North America, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report