Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2017 - (Recall #: Z-0007-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

Product Classification:

Class II

Date Initiated: July 21, 2017

Date Posted: October 11, 2017

Recall Number: Z-0007-2018

Event ID: 77788

Reason for Recall:

The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.

Status: Terminated

Product Quantity: 50 units

Code Information:

Product Code 9048-13H, Lot No. 81080

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated