The Recall Desk
HighFDA (Devices)·Z-1793-2012·Announced 2012-06-20

Aesculap Recalls Columbus Tibia Plateau Components Due to Specification Defects

Aesculap Implant Systems is recalling eight Columbus Tibia Plateau components because they were found out of specification during internal quality inspection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device with a structural defect (misalignment) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Aesculap Implant Systems is recalling eight units of the Columbus Tibia Plateau, a component of the Columbus REVISION Knee System. The recall was initiated after an internal quality inspection revealed that the tibia plateau was out of specification.

The defect presents a potential for misalignment between the tibia plateau and the attachment of the extension stem. The Columbus Revision Knee System is indicated for the reconstruction of diseased knee joints caused by osteoarthritis, rheumatic arthritis, post-traumatic arthritis, or the need to revise failed arthroplastics or osteotomies.

The affected units were distributed nationwide, including Pennsylvania and Texas. The specific product codes involved are NR068K, NR070K, NR072K, NR073K, NR074K, NR075K, NR076K, NR077K, NR078K, and NR079K. Healthcare providers and patients should contact Aesculap Implant Systems for further instructions regarding the recall.

The recalled product

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 rev
Manufacturer
Aesculap Implant Systems
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • NR068K
  • TIBIA PLATEAU
  • FIXED
  • T0
  • NR070K
  • T0+
  • NR072K
  • T1
  • T1+
  • NR073K
  • T2
  • NR074K
  • T2+
  • NR075K
  • T3
  • NR076K
  • T3+
  • NR077K
  • T4
  • NR078K

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same hazard · misalignment

See all →