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Recall Observatory FDA recall evidence

Device product

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

Z-1793-2012

February 21, 2012

Class II

Product summary

Firm
Aesculap Implant Systems
Event
Event 61332
Status
Terminated
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-1793-2012

Official wording

Reason: 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.

Code information: 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

Distribution pattern: Nationwide Distribution including PA and TX.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification