Recall Z-1112-2017— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-1112-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-12

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2016-12-12, terminated 2017-05-22. It names one FDA 510(k) clearance: K090234. Product: SwishTapered Implant. Reason: The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Terminated: 2017-05-22
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

SwishTapered Implant

Reason for recall

The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

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