Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
- Recall Initiated
- July 21, 2017
- Terminated
- April 1, 2021
- Recall Number
- Z-0007-2018
- Quantity
- 50 units
- Firm Location
- Westlake Village, CA
Reason for Recall
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Distribution
Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
Lot / Code Info
Product Code 9048-13H, Lot No. 81080
Root Cause
Employee error
Action Taken
Recall notification letters were sent to consignees, via mail on 07/21/2107. Instructions included to review current inventory and remove affected product, to complete and return the Acknowledgement and Recall Return form, and to notify customers who received product if it was further distributed.
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