The Recall Desk

FDA (Devices) recall action 80534

Zimmer Biomet, Inc. recalled 2 products on 2018-08-22

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
2018-08-22
Critical
0
Units
24

Why these products were recalled

Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

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)··2018-08-22

    Zimmer Biomet Recalls ARCOS Modular Revision Hip System Femoral Stems

    Zimmer Biomet is recalling 12 ARCOS Modular Revision Hip System femoral stems because they may have been mixed with Echo BI-Metric stems, potentially extending surgery time.

    Product
    ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem.
    Category
    Distribution
    6 states
  • ModerateFDA (Devices)··2018-08-22

    Zimmer Biomet Recalls Echo Hip Stems Due to Potential Component Comingle

    Zimmer Biomet is recalling 12 Echo Bi-Metric Hip Stems because they may have been mixed with a different model. The error could extend surgery time.

    Product
    ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
    Category
    Distribution
    6 states