# FDA recall Z-0401-2021

> **Merz North America, Inc.** · Class II · device recall initiated 2020-09-30.

## 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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0401-2021
- **Recalling firm:** Merz North America, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-30
- **Report date:** 2020-11-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Franksville, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0401-2021

## Citation

> AI Analytics. FDA recall Z-0401-2021. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-0401-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*