Class 2 Device Recall COAPTITE

• Date Initiated by Firm: September 30, 2020
• Create Date: November 16, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0401-2021
• Recall Event ID: 86572
• PMA Number: P040047
• Product Classification: Agent, bulking, injectable for gastro-urology use - Product Code LNM
• 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.
• Code Information: Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615
• Recalling Firm/ Manufacturer: Merz North America, Inc.; 4133 Courtney Rd Ste 10; Franksville WI 53126-9127
• For Additional Information Contact: Boston Scientific Call Center; 866-868-4004
• Manufacturer Reason for Recall: The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
• FDA Determined Cause: Labeling design
• Action: 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.
• Quantity in Commerce: 2051 units
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LNM