Z-0007-2018Class II

Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant...

Name: Z-0007-2018 Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2017-07-21
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2017-07-21 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component on 2017-07-21. FDA classified it as Class II and gives the reason as "The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component". 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-0007-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-21
Posted: 2017-10-03
Terminated: 2021-04-01
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Recall notification letters were sent to consignees, via mail on 07/21/2107. Instructions included to review current inventory and remove affected product, to complete and return the Acknowledgement and Recall Return form, and to notify customers who received product if it was further distributed.
Quantity in commerce: 50 units
Distribution: Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
Product codes and lots: Product Code 9048-13H, Lot No. 81080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0007-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0007-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-11	2017-10-03

Product code NHA

K090234Class IISpectra System Dental Implants 2008Implant Direct, LLC / cleared 2009-05-15

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)