Z-0007-2018 Class II Terminated
FDA device recall Z-0007-2018 was initiated by Implant Direct Sybron Manufacturing, LLC on July 21, 2017 and is designated Class II. Reason for recall: The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component. The recall status is terminated (terminated April 1, 2021). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2017
- Initiation Date
- July 21, 2017
- Termination Date
- April 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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 Pattern
Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
Code Information
Product Code 9048-13H, Lot No. 81080