UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
- Company
- Ultradent Products, Inc.
- Recall Initiated
- November 17, 2016
- Posted
- December 3, 2016
- Terminated
- June 5, 2017
- Recall Number
- Z-0704-2017
- Quantity
- 31
- Firm Location
- South Jordan, UT
Reason for Recall
There was a labeling error with product, UltraSeal XT Plus Clear Refill, Part Number (PN) 565, Lot Number (Lot) BD79T. The package was mislabeled as PQ1, PN 641; while the barcode, IFU and products were labeled for UltraSeal XT Plus Clear Refill, PN 565, Lot BD79T.
Distribution
Worldwide Distribution - US Nationwide
Lot / Code Info
Lot BD79T
Root Cause
Labeling mix-ups
Action Taken
Consignees notified via phone on 17Nov2016 and by letter on 22Nov2016 to identify and return products. Consignees with any questions regarding this field action can be sent to 801-553-4858 or 801-553-4220.
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