BioPro recalled 147 Endo Head Ceramic implant components distributed in Texas and Michigan after packaging could compromise the sterile barrier. The defect could result in loss of sterility of the device, creating an infection risk if implanted. Clinicians and patients should stop using the devices and contact BioPro for instructions and refunds.
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BioPro, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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BioPro Endo Head ceramic components are used in dental implant procedures. These parts come in multiple sizes and IDs to fit different implants.
A packaging defect could allow a breach in the sterile barrier, which may lead to infection if the device is implanted.
This recall is not part of a broader industry pattern.
Implant surgeries may require scheduling changes. Patients could face infection risk if an affected device is implanted, and clinicians must coordinate replacements or testing as needed.
FDA enforcement page and BioPro recall notice. The UDI-DI codes are listed with each model.
Recall communications with healthcare providers will occur within weeks. Replacements or refunds depend on the provider and BioPro.
Maintain all recall notices, packaging photos, device IDs, lot numbers, and correspondence with BioPro and healthcare providers.
Model numbers: 13006, 13012, 13013, 13019, 13007, 13008, 13009, 13010, 13011, 13014, 13015, 13016, 13017, 13018, 14823, 14824, 14825, 14826, 17295, 17296. Sold in US domestic distribution to Texas and Michigan. When sold: Unknown. Price: Unknown. All lots.
No injuries or incidents have been reported.
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