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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83573

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 06, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Implant Direct Sybron Manufacturing, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0261-2020
Recall number
Z-0261-2020
Initiated
September 06, 2018
Classification
Class II
Status
Terminated
Quantity
107 Scan Adapters

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
incorrect assembly

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Part numbers/Lot Numbers: 6035-09PT/Lot # 104539; 6043-09PT/ Lot # 104540; 6050-09PT/Lot # 104511

Distribution pattern

US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia,