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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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
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