Recall Z-0185-2018— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-0185-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-10

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2017-10-10, terminated 2018-09-27. It names one FDA 510(k) clearance: K090234. Product: ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.. Reason: One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-10-10
Terminated: 2018-09-27
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

ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Reason for recall

One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.

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