FDA Medical Device Recalls (openFDA)
Merz North America, Inc.: 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.
- Recall number
- Z-0401-2021
- Recalling firm
- Merz North America, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2020-09-30
- Posted
- not on file
- Terminated
- not on file
- Reason
- The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
- Root 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
- 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
- Lot, serial or model codes
- Model M0068903000, Lots: 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615
- 510(k) numbers
- not on file
- PMA numbers
- ["P040047"]
- Product code
- LNM
- Firm FEI
- 3003407669
- Firm city
- Franksville
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28