Z-0363-2020Class II

Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD...

Name: Z-0363-2020 Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2018-10-26
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2018-10-26 / Terminated / root cause: packaging

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant on 2018-10-26. FDA classified it as Class II and gives the reason as "packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit". 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-0363-2020
Classification: Class II
Status: Terminated
Initiated: 2018-10-26
Posted: 2019-11-12
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Root cause tag: packaging
FDA root cause: Packaging
Action: On 10/25/2018, a "URGENT: MEDICAL DEVICE RECALL" letter was sent to consignees via FedEx Priority overnight. The notification stated the following: 1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement Form within 48 hours for the product listed above; Quarantine product and return product listed above. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC 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. 4.If you have any of the affected product listed above, please return the product and we will send you a replacement part. 5.If you have any questions contact Implant Direct Sybron LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. 6. If you or your patients have experienced any issues as a result of the affected products noted in this communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
Quantity in commerce: 53 implants
Distribution: US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
Product codes and lots: Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0363-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0363-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-12

Product code DZE

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)