Aesculap Recalls Mislabelled Knee Implant Packaging for Cementless Use
Aesculap Inc. is recalling 1,232 units of Columbus Revision and EnduRo Knee System packaging labeled as cementless, which are indicated for use with bone cement only.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling error (mislabeling) on a medical device. While the agency classification is Class II, the hazard is a documentation/labeling issue rather than a structural defect or contamination, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Aesculap Inc. has initiated a recall for Tibial and Femur extension sterile pressfit stem implant packaging used for the Columbus Revision and EnduRo Knee Systems. The recall involves 1,232 units distributed nationwide in the United States.
The reason for the recall is that the packaging is labeled as "Cementless," but the US product is indicated for use with Bone Cement only. This labeling discrepancy could lead to improper surgical technique if the packaging is relied upon for clinical decision-making.
Healthcare providers and facilities should stop using the affected packaging and contact Aesculap Inc. for further instructions. Consumers are not directly affected as these are surgical implants used by medical professionals.
The recalled product
- Product
- Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.
- Manufacturer
- Aesculap, Inc.
- Hazard
- Affected units
- 1,232
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 (1)
- All codes
Distribution
Distributed nationwide across the United States.
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