Lower riskMedical device recall · FDA · Published September 6, 2018
Implant Direct Scan Adapter Assembly Recall: Incorrect Assembly May Cause Scanning Delays
Implant Direct recalls scan adapter assemblies with part numbers 6035-09PT-M, 6043-09PT-M, and 6050-09PT-M that may cause scanning delays due to incorrect assembly. Affected units include specific lot numbers and part numbers listed in the recall notice.
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.
Take action
Contact the company
📍Recalling firmImplant Direct Sybron Manufacturing, LLC3050 E Hillcrest Dr · Westlake Village, CA 91362-3171
“Implant Direct Scan Adapter Assembly Recall: Incorrect Assembly May Cause Scanning Delays.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69901-implant-direct-scan-adapter-assembly-recall-incorrect-assembly-may-cause. Based on FDA recall #Z-0261-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0261-2020%22&limit=1).
Implant Direct Sybron Manufacturing LLC recalled Implant Direct Scan Adapter Assemblies due to incorrect assembly hazards, the FDA said on Sept. 6, 2018. The error could prevent clinicians from capturing implant positions during digital scanning.
How to tell if you have it
Brand: Implant Direct
Part numbers: 6035-09PT-M (3.5mmD), 6043-09PT-M (4.3mmD), 6050-09PT-M (5.00mmD)
The recall addresses incorrect assembly of the scan adapter. This defect could cause clinicians to fail to capture the position and orientation of a dental implant or lab analog during digital scanning, potentially resulting in patient delays.
Context
GovInfoNow's records show Implant Direct Sybron Manufacturing LLC has had 20 other recalls since June 26, 2017. Recent brand recalls include a May 1, 2025 recall for incorrect components in the Sybron Drill Stop Kit and a Sept. 23, 2021 recall for incorrect size labeling on Legacy 2 dental implants. Other recent recalls of similar products include Straumann Dental Implant Abutments (March 27, 2026) and Straumann Bone Level Tapered Implants (July 16, 2026).
How to tell if you have this one
Check for part numbers 6035-09PT-M, 6043-09PT-M, or 6050-09PT-M with specific lot numbers listed in the recall notice. The affected units include part numbers with UDI codes 10841307123934, 10841307123941, and 10841307123958.
Brand
Implant Direct
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify if your scan adapter has part numbers 6035-09PT-M, 6043-09PT-M, or 6050-09PT-M with the listed lot numbers.
Where it went and when
Where it was distributed
Distributed in 14 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia,” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Georgia, Louisiana, Massachusetts, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Utah, Virginia.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Check your product details against the listed part numbers and lot numbers to determine if it is affected. No specific action is required beyond checking.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0261-2020 (September 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0261-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.