Recall Z-1157-2020— Implant Direct Sybron Manufacturing LLC

Name: FDA recall Z-1157-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-11

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing LLC, initiated 2019-10-11, terminated 2024-04-12. It names one FDA 510(k) clearance: K090234. Product: Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,. Reason: Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery..

Recalling firm: Implant Direct Sybron Manufacturing LLC
Classification: Class II
Status: Terminated
Initiated: 2019-10-11
Terminated: 2024-04-12
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, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,

Reason for recall

Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

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