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.
- Company
- Merz North America, Inc.
- Recall Initiated
- September 30, 2020
- Recall Number
- Z-0401-2021
- Quantity
- 2051 units
- Firm Location
- Franksville, WI
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
Lot / Code Info
Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615
Root Cause
Labeling design
Action Taken
Merz NA, in cooperation with Boston Scientific Corporation (BSC) have prepared field action communications including a Medical Device Field Notification Letter and Urgent Medical Device Field Notification Response Form. These letters will be sent via FedEx with delivery confirmation. The units at consignees will not be returned but will be furnished with an updated, revision-controlled IFU.