SwishTapered Implant Intended for use in support for fixed bridgework.
- Recall Initiated
- January 19, 2018
- Terminated
- July 26, 2023
- Recall Number
- Z-1167-2018
- Quantity
- 1,117 units total
- Firm Location
- Westlake Village, CA
Reason for Recall
The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Distribution
Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
Lot / Code Info
Part No. (Lot No.): 934106 (68075, 69252, 79574), 934112 (69101, 80912), 934806 (68076, 75219), 934812 (68078, 68889), 934814 (67980), and 935712 (68077).
Root Cause
Process control
Action Taken
Customers were sent Urgent: Safety Alert/Advisory Notice letters around 01/19/2018. The Notice identified the affected device and the reason for the correction. Instructions for both distributors and doctors include to review inventory for affected product, complete and return the Acknowledgement form within 48 hours of receipt of the letter, follow the included instructions to correct the affected product, and distributors are to notify those customers that may have been shipped the affected product lot and inform them of the issue. Questions should be directed to Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.