The Recall Desk

FDA (Devices) recall action 79406

Zimmer Biomet, Inc. recalled 2 products on 2018-04-04

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
2018-04-04
Critical
0
Units
36

Why these products were recalled

Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.

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)··2018-04-04

    Zimmer Biomet Recalls Mismatched Hip Implant Packages Due to Sizing Error

    Zimmer Biomet is recalling 24 hip implant packages labeled as size 7.5 Extended Offset Reduced Neck length that actually contained Size 4 Standard Reduced Neck length implants.

    Product
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
    Category
    Distribution
    12 states
  • ModerateFDA (Devices)··2018-04-04

    Zimmer Biomet Recalls Mismatched Hip Implant Packages

    Zimmer Biomet is recalling 12 hip implant packages labeled as size 7.5 that actually contained size 4 implants.

    Product
    Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40
    Category
    Distribution
    12 states