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
Reported: May 2, 2018 Initiated: January 12, 2018 #Z-1512-2018
Product Description
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
Reason for Recall
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 6 units of catalog 5521-B-400
- Distribution
- Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Howmedica Osteonics Corp.. Units affected: 6 units of catalog 5521-B-400.
Why was this product recalled? ▼
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 2, 2018. Severity: Moderate. Recall number: Z-1512-2018.
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