Z-1167-2018Class II

SwishTapered Implant Intended for use in support for fixed bridgework

Name: Z-1167-2018 SwishTapered Implant Intended for use in support for fixed bridgework
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2018-01-19
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2018-01-19 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of SwishTapered Implant Intended for use in support for fixed bridgework on 2018-01-19. FDA classified it as Class II and gives the reason as "The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer)". 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-1167-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-19
Posted: 2018-03-22
Terminated: 2023-07-26
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: SwishTapered Implant Intended for use in support for fixed bridgework.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were sent Urgent: Safety Alert/Advisory Notice letters around 01/19/2018. The Notice identified the affected device and the reason for the correction. Instructions for both distributors and doctors include to review inventory for affected product, complete and return the Acknowledgement form within 48 hours of receipt of the letter, follow the included instructions to correct the affected product, and distributors are to notify those customers that may have been shipped the affected product lot and inform them of the issue. Questions should be directed to Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Quantity in commerce: 1,117 units total
Distribution: Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
Product codes and lots: Part No. (Lot No.): 934106 (68075, 69252, 79574), 934112 (69101, 80912), 934806 (68076, 75219), 934812 (68078, 68889), 934814 (67980), and 935712 (68077).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1167-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1167-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22
Z-1168-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-28	2018-03-22

Product code DZE

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)