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Recall Observatory FDA recall evidence

Device product

Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function

Z-1512-2018

January 12, 2018

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 79661
Status
Terminated
Classification
Class II
Quantity
6 units of catalog 5521-B-400
Official record key
device-enforcement:Z-1512-2018

Official wording

Reason: Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.

Code information: Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A

Distribution pattern: Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.