Recall Z-0010-2020— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-0010-2020
Creator: U.S. Food and Drug Administration
Published: 2018-08-07

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2018-08-07. It names one FDA 510(k) clearance: K061319. Product: ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.. Reason: The incorrect device was packaged in the vial..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-08-07
Firm location: Westlake Village, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K061319 — SPECTRA SYSTEMImplant Direct, LLC·cleared 2006-09-29

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 simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

Reason for recall

The incorrect device was packaged in the vial.

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