The Recall Desk

FDA (Devices) recall action 63641

Zimmer, Inc. recalled 2 products on 2012-12-26

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
2012-12-26
Critical
0
Units
40

Why these products were recalled

Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .

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

  • HighFDA (Devices)··2012-12-26

    Zimmer Recalls Coonrad/Morrey Total Elbow Replacement Sets Due to Pin Error

    Zimmer, Inc. is recalling specific lots of Coonrad/Morrey Total Elbow Replacement Sets because they may contain an incorrect small inner pin instead of the required regular pin.

    Product
    COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-12-26

    Zimmer Recalls Coonrad/Morrey Elbow Replacement Kits Due to Pin Error

    Zimmer is recalling specific lots of Coonrad/Morrey elbow replacement kits because they may contain an incorrect small inner pin instead of the required regular pin.

    Product
    Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the soli
    Category
    Distribution
    0 states