The Recall Desk

FDA (Devices) recall action 78762

Zimmer Biomet, Inc. recalled 2 products on 2018-03-07

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
2018-03-07
Critical
0
Units
41,419

Why these products were recalled

The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.

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

  • HighFDA (Devices)··2018-03-07

    Zimmer Biomet Recalls Segmental System Distal Femur Components

    Zimmer Biomet is recalling 3,350 units of the Segmental System, ZSS Distal Femur, because the products exceeded tested weights, potentially compromising the sterile barrier.

    Product
    Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the pro
    Category
    Distribution
    48 states
  • HighFDA (Devices)··2018-03-07

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Sterile Barrier Risk

    Zimmer Biomet is recalling 38,069 units of Versys 6 inch Beaded Full Coat Plus Hip Prostheses because weight issues may have compromised the sterile barrier.

    Product
    Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); c. VERSYS 6 INCH BEADED FC 22X160MM STD BO
    Category
    Distribution
    48 states