Recall Z-1920-2018— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-1920-2018
Creator: U.S. Food and Drug Administration
Published: 2016-11-15

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2016-11-15, terminated 2018-06-04. It names one FDA 510(k) clearance: K090234. Product: ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.. Reason: The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-11-15
Terminated: 2018-06-04
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 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.

Reason for recall

The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.

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