Recall Z-0364-2020— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-0364-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-09

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2019-08-09, terminated 2021-04-27. It names one FDA 510(k) clearance: K090234. Product: Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants. Reason: A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-08-09
Terminated: 2021-04-27
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, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

Reason for recall

A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

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