Recall Z-0363-2020— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-0363-2020
Creator: U.S. Food and Drug Administration
Published: 2018-10-26

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2018-10-26. It names one FDA 510(k) clearance: K130572. Product: Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant. Reason: packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-10-26
Firm location: Westlake Village, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K130572 — INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEMImplant Direct Sybron Manufacturing, LLC·cleared 2013-12-24

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, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant

Reason for recall

packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.

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