Aesculap Columbus Revision CoCr Spacers Recalled Due to Incompatibility
Aesculap, Inc. is recalling 24 Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7, because they were not compatible.
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: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Aesculap, Inc. is recalling 24 units of Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7. The recall is being conducted because the spacers were not compatible.
The affected products are identified by the following lot numbers: 51468773, 51447588, 51468302, 51503760, 51571394, 51585136, and 51447597. The products were distributed in Florida and Maryland.
Healthcare providers and patients should stop using these specific spacers and contact Aesculap, Inc. for further instructions or a replacement.
The recalled product
- Product
- Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
- Manufacturer
- Aesculap, Inc.
- Hazard
- Affected units
- 24
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 (7)
- lots: 51468773
- 51447588
- 51468302
- 51503760
- 51571394
- 51585136
- 51447597
Distribution
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