Z-0791-2020Class II

ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The...

Name: Z-0791-2020 ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The...
Creator: Implant Direct Sybron Manufacturing, LLC
Published: 2018-11-28
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2018-11-28 / Completed / root cause: manufacturing process

FDA source

Implant Direct Sybron Manufacturing, LLC began a recall of ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron... on 2018-11-28. FDA classified it as Class II and gives the reason as "The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0791-2020
Classification: Class II
Status: Completed
Initiated: 2018-11-28
Posted: 2020-01-08
Recalling firm: Implant Direct Sybron Manufacturing LLC
Product: ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm first issued recall letters on 11/28/2018 via FedEx for Part number 6534-09PT and then on 12/28/2018, issued recall letters for Part number 6530-09PT via FedEx. On 2/14/2019, the firm issued another letter to their consignees that added a risk statement regarding the recall of both part numbers (6534-09PT and 6530-09PT).
Quantity in commerce: 232 devices
Distribution: Distribution was made to AL, AZ, CA, FL, GA, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, and VA. There was no government/military distribution. Foreign distribution was made to Canada, Armenia, Australia, Denmark, France, Germany, Great Britain, Iceland, Italy, Lithuania, Netherlands, Poland, Spain, Sweden, and Switzerland.
Product codes and lots: Lot numbers 104151, 106478, 114914, and 124072.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0791-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0790-2020	Class II	Completed	Voluntary: Firm initiated	2020-01-15	2020-01-08
Z-0791-2020	Class II	Completed	Voluntary: Firm initiated	2020-01-15	2020-01-08

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)