COAPTITE Injectable Implant — Class II medical device recall Z-0401-2021
Ongoing recall by Merz North America, Inc., reported 2020-11-25, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
| Recall number | Z-0401-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merz North America, Inc., Franksville, WI, United States |
| Recall initiated | 2020-09-30 |
| Classified | 2020-11-16 |
| Reported by FDA | 2020-11-25 |
| Distributed | 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 |
| Quantity | 2,051 units |
| Lot numbers | 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, 100129615 |
| Model numbers | 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, 100129615, M0068903000 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0401-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.