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Merz North America Recalls
5 recalls on record · December 9, 2015 to November 25, 2020 · Medical Devices
Recalls by year
15
16
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 25, 2020Medical DevicesFDA
Merz North America, Inc. recalls COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns
Hazard: The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
August 31, 2016Medical DevicesFDA
Merz North America, Inc. recalls Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE i
Hazard: Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
December 9, 2015Medical DevicesFDA
Merz North America, Inc. recalls PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An
Hazard: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
December 9, 2015Medical DevicesFDA
Merz North America, Inc. recalls PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstruct
Hazard: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
December 9, 2015Medical DevicesFDA
Merz North America, Inc. recalls Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction
Hazard: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.