Howmedica Recalls Six Knee Prosthesis Units Due to Incorrect Size Labeling
Howmedica Osteonics Corp. is recalling six sterile knee prosthesis units because the implant size may not match the box label.
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 hazard involves a labeling error where the implant size may not match the box. No injuries or illnesses are reported, fitting the criteria for a moderate severity recall.
Plain-English summary
Howmedica Osteonics Corp. is recalling six sterile, single-use knee prosthesis units intended for revision total knee arthroplasty. The recall involves catalog 5521-B-400, lot code ATY40A.
The firm became aware that the specific product and lot combinations may contain an incorrect size implant from what is labeled on the box. The affected products were sent to three medical facilities.
Affected product will be returned to the manufacturer for disposition. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
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 (3)
- Catalog 5521-B-300
- lot code ATV7IA Catalog 5521-B-400
- lot code ATY40A
Distribution
Distribution scope not specified by the agency.
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