The Recall Desk

FDA (Devices) recall action 66846

Zimmer, Inc. recalled 2 products on 2014-01-29

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
2014-01-29
Critical
0
Units
10,610

Why these products were recalled

After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.

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.

1–2 of 2

  • ModerateFDA (Devices)··2014-01-29

    Zimmer Segmental Systems Polyethylene Inserts Recalled for Loading Instructions

    Zimmer, Inc. is recalling Segmental Systems Polyethylene Inserts to update surgical instructions regarding excessive loading risks.

    Product
    Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
    Category
    Distribution
    0 states