Z-1112-2017Class II

SwishTapered Implant

Name: Z-1112-2017 SwishTapered Implant
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2016-12-12
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2016-12-12 / Terminated / root cause: packaging

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of SwishTapered Implant on 2016-12-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1112-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Posted: 2017-01-28
Terminated: 2017-05-22
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: SwishTapered Implant
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Customer notification letters were sent on 12/12/16. Customers were requested to review inventory for the affected product. Complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized distributor the firm requests that they identify those customers that may have been shipped the affected product lot and contact those customers to inform them of the issue within 48 hours of receipt of the notification in order to provide the customers with replacement product. If customers have any of the affected product the firm will send a replacement part. Any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.
Quantity in commerce: 17
Distribution: U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
Product codes and lots: 933308 Lot # 73241

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1112-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1112-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)