Recall Z-1512-2018— Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2018-01-12, terminated 2020-05-07. It names one FDA 510(k) clearance: K141056. 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. 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..
- Recalling firm
- Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-12
- Terminated
- 2020-05-07
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.