Z-0261-2020Class II

Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M...

Name: Z-0261-2020 Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2018-09-06
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2018-09-06 / Terminated / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI... on 2018-09-06. FDA classified it as Class II and gives the reason as "The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s)...". 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-0261-2020
Classification: Class II
Status: Terminated
Initiated: 2018-09-06
Posted: 2019-10-31
Terminated: 2021-07-01
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On X/xx/xxx, consignees were mailed a "Urgent: Medical Device Recall" letter via XXX. The recall notification asked customers to do 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, please return the product and we will send you a replacement part. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. 5.If you or your patients has 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: 107 Scan Adapters
Distribution: US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia,
Product codes and lots: Part numbers/Lot Numbers: 6035-09PT/Lot # 104539; 6043-09PT/ Lot # 104540; 6050-09PT/Lot # 104511

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0261-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0261-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-06	2019-10-31

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)