Reported May 2, 2018 · Terminated
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision…
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- Knee Prosthesis, Sterile
- Single-Use devices Product UsageThe knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
- Lot codes and dates
Catalog 5521-B-300lot code ATV7IA Catalog 5521-B-400lot code ATY40A
- Amount recalled
- 6 units of catalog 5521-B-400
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Howmedica Osteonics Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.