Recall Z-0961-2017— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-0961-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-28

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2016-11-28, terminated 2017-02-16. It names one FDA 510(k) clearance: K090234. Product: GoDirect Screw-Retaining Top Part Numbers: 4500-61. Reason: Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-11-28
Terminated: 2017-02-16
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

GoDirect Screw-Retaining Top Part Numbers: 4500-61

Reason for recall

Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

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