Recall Z-0007-2018— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-0007-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-21

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2017-07-21, terminated 2021-04-01. It names one FDA 510(k) clearance: K090234. Product: Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.. Reason: The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-07-21
Terminated: 2021-04-01
Firm location: Westlake Village, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K090234 — SPECTRA SYSTEM DENTAL IMPLANTS 2008Implant Direct, LLC·cleared 2009-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.