Recall Z-0539-2018— Implant Direct Sybron Manufacturing, LLC

Name: FDA recall Z-0539-2018
Creator: U.S. Food and Drug Administration
Published: 2018-01-23

Class II · Terminated

Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2018-01-23, terminated 2018-08-09. It names one FDA 510(k) clearance: K130572. Product: Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform. Reason: InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized..

Recalling firm: Implant Direct Sybron Manufacturing, LLC
Classification: Class II
Status: Terminated
Initiated: 2018-01-23
Terminated: 2018-08-09
Firm location: Westlake Village, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K130572 — INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEMImplant Direct Sybron Manufacturing, LLC·cleared 2013-12-24

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

Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform

Reason for recall

InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.

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