Recall Z-2320-2016— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-2320-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-05

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2016-07-05, terminated 2017-02-16. It names one FDA 510(k) clearance: K061319. Product: RePlant¿ Angled Abutment Part Number 6050-52-60. Reason: Issue with design specification; oversized condition..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-07-05
Terminated: 2017-02-16
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

RePlant¿ Angled Abutment Part Number 6050-52-60

Reason for recall

Issue with design specification; oversized condition.

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