Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
This recall has been terminated (originally issued May 29, 2018).
- Recall Initiated
- May 29, 2018
- Terminated
- July 29, 2020
- Recall Number
- Z-0089-2019
- Quantity
- 217 units
- Firm Location
- Thousand Oaks, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
Distribution
Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.
Lot / Code Info
Part number 8735-05, Lot number 90212
Root Cause
Process control
Action Taken
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.