The Recall Desk

Manufacturer

Merz North America, Inc.

5 recalls in our database name Merz North America, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2020-11-25

Of the 5 recalls from Merz North America, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • LowFDA (Devices)·Z-0401-2021·2020-11-25

    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.

    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
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-2607-2016·2016-08-31

    Merz Recalls Radiesse Injectable Implant Due to Syringe Delivery Issues

    Merz North America is recalling 1,591 units of Radiesse (+) Lidocaine Injectable Implant because the product could not be expelled from the syringe or needle.

    Product
    Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0368-2016·2015-12-09

    Merz Recalls Prolaryn Plus Injectable Implant Due to Incorrect Expiration Date

    Merz North America is recalling Prolaryn Plus Injectable Implants because the expiration date on the labels is incorrect. The recall covers 9,439 units distributed in the US and South Africa.

    Product
    PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0367-2016·2015-12-09

    Merz Recalls Prolaryn Injectable Implant Due to Incorrect Expiration Date

    Merz North America is recalling Prolaryn Injectable Implant 1.0 cc Gel because the expiration date on the label is incorrect.

    Product
    PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0366-2016·2015-12-09

    Merz Recalls Radiesse Injectable Implant Due to Incorrect Expiration Date

    Merz North America is recalling 1,616 units of Radiesse (+) Lidocaine Injectable Implant because the expiration date on the packaging is incorrect.

    Product
    Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds.
    Category
    Medical Device
    Distribution
    Distributed nationwide