Howmedica Osteonics recalled 55 units of surgical stems on August 28, 2025, due to a potential product mix. Packages labeled as Catalog Number 0580-1-442 may contain Catalog Number 0580-1-352, leading to possible patient safety risks.
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Howmedica Osteonics Corp. or your healthcare provider for instructions. Notification method: Letter
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The recall involves two model numbers: 0580-1-442 and 0580-1-352. The affected items were distributed internationally, specifically in the United Kingdom.
The potential product mix can lead to incorrect usage of the surgical stems, posing a risk to patient safety. This recall has been classified as Class II by the FDA.
There were no specific incidents or injuries reported at the time of recall. The risk of incorrect labeling presents a high safety concern.
Patients and healthcare providers must stop using these devices immediately. Contact Howmedica Osteonics Corp. or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2640-2025.
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