Recall Z-2376-2018— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-2376-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-18

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2018-05-18, terminated 2020-07-13. It names one FDA 510(k) clearance: K061319. Product: REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60. Reason: Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant.

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-05-18
Terminated: 2020-07-13
Firm location: Thousand Oaks, 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 5.0mmD ABUTMENT, Part number 6050-52-60

Reason for recall

Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant

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