Recall Z-1041-2020— Implant Direct Sybron Manufacturing LLC

Name: FDA recall Z-1041-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-07

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing LLC, initiated 2019-10-07, terminated 2021-04-28. It names one FDA 510(k) clearance: K090234. Product: Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213. Reason: Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling..

Recalling firm: Implant Direct Sybron Manufacturing LLC
Classification: Class II
Status: Terminated
Initiated: 2019-10-07
Terminated: 2021-04-28
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

Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

Reason for recall

Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

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