Osteotec Limited recalls Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Num…

There is the potential that the silicone implant may contain foreign material

On June 18, 2025, Osteotec issued an Urgent Medical Device Recall Notification via E-Mail. Osteotec asked consignees to take the following actions: 1. Immediately review your inventory and quarantine any of the affected LOTs. 2. If a physician has successfully implanted the device, they physician should continue to monitor the implant for any infections or issues. If a physician has successfully implanted a device that potentially could contain foreign material, it is recommended that they continue to monitor the patient for any infections or issues associated with the recalled device. 3. Share this Product Recall letter within your facility network and forward to any customers to whom you have distributed products from the affected LOTs to ensure awareness. 4. Complete and return the attached response and acknowledgement form to Osteotec. 5. Return affected products to your Agent/Distributor/Osteotec

• FDA enforcement recordOfficial FDA database entry for Z-2222-2025
• FDA 510(k) clearance · K140453The device's official FDA premarket clearance record
• FDA device classification · KYJOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3230The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Osteotec LimitedSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.