FDA Device recall Z-0401-2021
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calc…
- FDA Device
- Class II
- ongoing
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calc… by Merz North America, citing the Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0401-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-30 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Merz North America |
| 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 |
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
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
Identifiers
| code_info | Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0401-2021%22
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