Merz North America, Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Merz North America, Inc.
Lot Codes / Batch Numbers
Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615
Products Sold
Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615
Merz North America, Inc. is recalling COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical partic due to The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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
Page updated: Jan 10, 2026