Z-0539-2018Class II

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

Name: Z-0539-2018 Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2018-01-23
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2018-01-23 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform on 2018-01-23. FDA classified it as Class II and gives the reason as "InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0539-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-23
Posted: 2018-02-06
Terminated: 2018-08-09
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated their recall on 01/23/2018 by letter. the recall notices requested the following actions by the distributors: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours. 3. If you are an authorized Implant Direct Sybron Manufacturing distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification in order to provide the customers with replacement product." The letter disseminated to the physician requested the following actions: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours."
Quantity in commerce: 55 units
Distribution: CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands
Product codes and lots: Lot Number 104203

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0539-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0539-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06

Product code NHA

K130572Class IIInteractive/ Swishplus2 Implant SystemImplant Direct Sybron Manufacturing, LLC / cleared 2013-12-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)