FDA recall Z-0007-2018

Implant Direct Sybron Manufacturing, LLC · Class II · device

Product

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

Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.

Key facts

Status
Terminated
Initiation date
2017-07-21
Report date
2017-10-11
Termination date
2021-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Westlake Village, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0007-2018