Recall Z-0197-2022— Implant Direct Sybron Manufacturing LLC

Name: FDA recall Z-0197-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-23

Class II · Ongoing

Class II FDA medical device recall by Implant Direct Sybron Manufacturing LLC, initiated 2021-09-23. It names one FDA 510(k) clearance: K192221. Product: ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,. Reason: Packaged dental implant contains a different size then the size declared on the labeling..

Recalling firm: Implant Direct Sybron Manufacturing LLC
Classification: Class II
Status: Ongoing
Initiated: 2021-09-23
Firm location: Westlake Village, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K192221 — Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mountsImplant Direct Sybron Manufacturing, LLC·cleared 2020-06-25

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

ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

Reason for recall

Packaged dental implant contains a different size then the size declared on the labeling.

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