Reported Jun 20, 2012 · Terminated
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee…
Aesculap Implant Systems
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: Aesculap Implant Systems · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 NR068K, TIBIA PLATEAU, FIXED, T0 2 NR070K, TIBIA PLATEAU, FIXED, T0+ 3 NR072K, TIBIA PLATEAU, FIXED, T1 4 NR072K, TIBIA PLATEAU, FIXED, T1+ 5 NR073K, TIBIA PLATEAU, FIXED, T2 6 NR074K, TIBIA PLATEAU, FIXED, T2+ 7 NR075K, TIBIA PLATEAU, FIXED, T3 8 NR076K, TIBIA PLATEAU, FIXED, T3+ 9 NR077K, TIBIA PLATEAU, FIXED, T4 10 NR078K, TIBIA PLATEAU, FIXED, T4+ 11 NR079K, TIBIA PLATEAU, FIXED, T5 - Amount recalled
- 8
Where it was sold
Why it was recalled
During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem.
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 Aesculap Implant Systems 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.