Z-0401-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- September 30, 2020
- Termination Date
- N/A
- 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