Z-0401-2021 Class II Ongoing
FDA device recall Z-0401-2021 was initiated by Merz North America, Inc. on Sep 30, 2020 and is designated Class II. Reason for recall: The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study. The recall status is ongoing. Affected quantity: 2051 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 25, 2020
- Initiation Date
- Sep 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2051 units
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.
Reason for recall
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
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
Code information
Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0401-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026