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Terminated

Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

FDA Recall Z-0089-2019 · Posted None

Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeNDP
Date Initiated2018-05-29
Date Terminated2020-07-29
Product Quantity217 units

Reason for Recall

Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.

Firm Action

On May 29, 2018, Implant Direct Sybron Manufacturing LLC issued URGENT MEDICAL DEVICE RECALL notices to their customers via FedEx overnight mail. Customers were instruction to take the following actions: 1. Review your inventory for the affected product. 2. Complete and return the Acknowledgement Form within 48 hours for the product listed; Quarantine and return impacted product. 3. Authorized Implant Direct Sybron Manufacturing LLC distributors, should identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within48 hours of receipt of the notification. Customers with questions may contact Implant Direct Sybron Manufacturing LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST.

Root Cause

Process control

Distribution Pattern

Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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