The Recall Desk

FDA (Devices) recall action 66809

Zimmer, Inc. recalled 5 products on 2013-12-18

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2013-12-18
Critical
0
Units
3,027

Why these products were recalled

This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulting in a delay. The associated implants would not be available due to the previous recall.

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.

1–5 of 5

  • HighFDA (Devices)··2013-12-18

    Zimmer NexGen Knee Instruments Recalled Due to Surgical Delay Risk

    Zimmer, Inc. is recalling five NexGen knee instruments to prevent their inadvertent use during surgery, which could cause delays.

    Product
    NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of j
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-12-18

    Zimmer NexGen Knee Implant Components Recalled for Surgical Delay Risk

    Zimmer, Inc. is recalling 638 NexGen Complete Knee Solution provisional articular surface devices. The recall is an expansion of a previous action to prevent inadvertent use of associated instruments.

    Product
    NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-12-18

    Zimmer NexGen Porous Patella Drill Guide Recall Expansion

    Zimmer, Inc. is expanding a recall of NexGen Porous Patella Drill Guides to prevent inadvertent use during surgery, which could cause delays.

    Product
    NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumat
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-12-18

    Zimmer NexGen Knee Instruments Recalled Due to Potential Surgical Delay

    Zimmer, Inc. is recalling five NexGen Micro knee instruments because they may be used incorrectly, causing surgical delays.

    Product
    NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic lo
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-12-18

    Zimmer NexGen Porous Patella Drill Guide Recall Expansion

    Zimmer, Inc. is expanding a recall of NexGen Porous Patella Drill Guides to include five additional instruments. These devices may be inadvertently used during surgery, causing delays.

    Product
    NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumat
    Category
    Distribution
    0 states