Merz North America, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0401-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 30, 2020

Date Posted: November 25, 2020

Recall Number: Z-0401-2021

Event ID: 86572

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2051 units

Code Information:

Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated