The Recall Desk

FDA (Devices) recall action 72591

Merz North America, Inc. recalled 2 products on 2015-12-09

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-12-09
Critical
0
Units
17,154

Why these products were recalled

The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··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
    Distribution
    1 state
  • ModerateFDA (Devices)··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
    Distribution
    1 state