CLASS II Device recall · Reported 20 Jun 2012 · FDA Enforcement Report
Columbus Tibia Plateau (component of the Columbus Revision recalled
Aesculap Implant Systems is recalling Columbus Tibia Plateau (component of the Columbus Revision Knee System), distributed nationwide in the US. The recall was initiated on 21 Feb 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1793-2012
- FDA event ID
- 61332
- Recalling firm
- Aesculap Implant Systems, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Feb 2012
- FDA classified
- 9 Jun 2012
- Reported
- 20 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 21 Feb 2012 | Recall initiated by company | |
| 9 Jun 2012 | Classified by FDA | +109 days |
| 20 Jun 2012 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution including PA and TX.
Questions about this recall
Is Columbus Tibia Plateau (component of the Columbus Revision Knee System) recalled?
Yes. Aesculap Implant Systems recalled Columbus Tibia Plateau (component of the Columbus Revision Knee System) on 21 Feb 2012. The recall is Class II and its status is Terminated. Recall number Z-1793-2012.
Why was it 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.
Which lots are affected?
NR068K, TIBIA PLATEAU, FIXED, T0; NR070K, TIBIA PLATEAU, FIXED, T0+; NR072K, TIBIA PLATEAU, FIXED, T1; NR072K, TIBIA PLATEAU, FIXED, T1+; NR073K, TIBIA PLATEAU, FIXED, T2; NR074K, TIBIA PLATEAU, FIXED, T2+; NR075K, TIBIA PLATEAU, FIXED, T3; NR076K, TIBIA PLATEAU, FIXED, T3+; NR077K, TIBIA PLATEAU, FIXED, T4; NR078K, TIBIA PLATEAU, FIXED, T4+; NR079K, TIBIA PLATEAU, FIXED, T5
Where was it sold?
Nationwide Distribution including PA and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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