Aesculap Implant Systems: Medical Device Recall in 2012 - (Recall #: Z-1793-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 21, 2012

Date Posted: June 20, 2012

Recall Number: Z-1793-2012

Event ID: 61332

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.

Status: Terminated

Product Quantity: 8

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.

Voluntary or Mandated:

Voluntary: Firm initiated