Straumann USA recalled 61 Emdogain demonstration devices distributed nationwide in 10 states. The devices, intended for demonstration only, could be placed in patients. Healthcare providers and patients should stop using immediately and follow recall instructions from Straumann for disposal or replacement.
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Straumann USA LLC or your healthcare provider for instructions. Notification method: Letter
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Emdogain is a dental regenerative product used in periodontal therapy. The recall concerns demonstration devices that were intended for display and training but may have been used on patients.
The hazard arises when demonstration devices are used on real patients, potentially exposing them to a product not intended for patient use.
This recall is not described as part of a broader industry pattern.
Clinicians must verify their inventories and stop use of affected devices. No injuries have been reported, but patient safety could be compromised if a demonstration device is used clinically.
Recall notices and identifiers are on the device labels and accompanying documentation. Official recall details are available from the recall notice linked in the source
Refunds or replacements are typically processed within 4-6 weeks after validation of eligibility
Keep the recall notice, device labels, lot numbers, purchase records, and any correspondence with the manufacturer
Two Emdogain demonstration devices are affected: Article Numbers 440.230V10 and 475.132V10. Lot numbers for 440.230V10 are EPZM8, HPT6, KEWN9, NAAM6, VAW80. Lot numbers for 475.132V10 are CRL56 and HPHJ1. A total of 61 units are involved. Distribution was nationwide in the United States, including AZ, CA, DE, FL, ID, MO, TN, TX, UT, and VA.
No injuries or incidents have been reported.
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