Reported Nov 25, 2020 · Ongoing
COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns…
Merz North America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merz North America, Inc. · 4133 Courtney Rd Ste 10 · Franksville, WI · 53126-9127
Is this the product you have?
- 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.
- Lot codes and dates
- Model M0068903000
- Lots
100127846100127847100128709100128710100129357100129614and 100129615
- Amount recalled
- 2051 units
Where it was sold
Why it was recalled
The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
This product could cause temporary or reversible health problems — stop using it.
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