Merz Recalls COAPTITE Injectable Implant Due to Documentation Mismatch
Merz North America is recalling 2,051 units of COAPTITE Injectable Implant because the Instructions for Use do not match post-approval study data.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation issue (mismatched Instructions for Use) with no reported injuries, illnesses, or physical product defects.
Plain-English summary
Merz North America, Inc. is recalling 2,051 units of COAPTITE Injectable Implant. The product is an injectable, sterile, non-pyrogenic implant composed of calcium hydroxylapatite particles suspended in a gel carrier. The affected units are packaged in 1.0cc syringes and sterile pouches.
The recall was initiated because the Instructions for Use (IFU), updated on March 2, 2020, do not match the data listed in the post-approval study. This is a documentation discrepancy rather than a physical defect in the implant itself.
The affected lots are 100127846, 100127847, 100128709, 100128710, 100129357, 100129614, and 100129615. These units were distributed in 48 states and the District of Columbia. Healthcare providers and patients should contact Merz North America, Inc. for further instructions regarding the return or disposal of these specific lots.
The recalled product
- 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
- Manufacturer
- Merz North America, Inc.
- Hazard
- Affected units
- 2,051
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Model M0068903000
- Lots: 100127846
- 100127847
- 100128709
- 100128710
- 100129357
- 100129614
- and 100129615
Distribution
Related recalls
Same manufacturer · Merz North America, Inc.
See all →- ModerateMerz Recalls Radiesse Injectable Implant Due to Syringe Delivery Issues
FDA (Devices) · 2016-08-31
- ModerateMerz Recalls Prolaryn Plus Injectable Implant Due to Incorrect Expiration Date
FDA (Devices) · 2015-12-09
- ModerateMerz Recalls Prolaryn Injectable Implant Due to Incorrect Expiration Date
FDA (Devices) · 2015-12-09
- ModerateMerz Recalls Radiesse Injectable Implant Due to Incorrect Expiration Date
FDA (Devices) · 2015-12-09
Same hazard · documentation error
See all →- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
- ModeratePower Over Fiber Base Modules Recalled Due to Incorrect Laser Classification and Labeling
FDA (Devices) · 2026-08-05
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01