Howmedica Osteonics recalled 55 units of EXETER V40 surgical stems distributed in the United Kingdom due to a risk of product mix. Patients may receive the incorrect product, potentially leading to surgical complications. Patients and healthcare providers must stop using the device and follow the manufacturer’s instructions.
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 EXETER V40 surgical stem is used in hip replacement surgeries, designed to provide stable and long-lasting support for hip implants. They are critical for patients undergoing hip surgeries and are typically used in conjunction with specific hip joint implants.
The hazard arises from a mix-up in packaging where one catalog number may contain the other model. Patients receiving the incorrect implant could face serious surgical complications or implant failure.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must address the recall promptly to prevent any potential surgical complications due to incorrect implant usage.
Catalog numbers and lot information can typically be found on the product packaging or directly on the device itself.
Expect a refund processing timeline of about 4-8 weeks after returning the product.
Keep records of your device details, purchase information, and any correspondence related to the recall.
1. Catalog Number: 0580-1-442, Lot Number: A00976 2. Catalog Number: 0580-1-352, Lot Number: G8754849 3. Distributed in the United Kingdom only. 4. Price: Unknown.
No injuries or incidents have been reported.
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