Reported Sep 19, 2012 · Terminated
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended…
Omni Life Science
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: Omni Life Science · 50 Oconnell Way · East Taunton, MA · 02718
Is this the product you have?
- Omnilife Science Apex Knee System Modular Tibia Augment
- Size 1 x 4mm RefKC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement
- Lot codes and dates
- Lot Numbers
836185258894893089759167916910220103131071711547
- Lot Numbers
- Amount recalled
- 312 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility
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 Omni Life Science 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.