SwishPlus Implant Intended for use in support for fixed recall
SwishPlus Implant Intended for use in support for fixed bridgework.
Why was SwishPlus Implant Intended for use in support for fixed recalled?
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).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).
- Product
- SwishPlus Implant Intended for use in support for fixed bridgework.
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 1,117 units total
- Distribution
- Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
- Recall date
- March 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)