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.
Implant Direct is recalling scan adapter assemblies that may cause delays in dental scanning due to incorrect assembly. This could lead to longer wait times for patients needing dental implants. The recall affects specific part numbers and lot numbers.
The scan adapter assemblies may be incorrectly assembled, which can prevent clinicians from accurately capturing the position and orientation of dental implants or lab analogs during digital scanning. This issue could result in delays for patients needing dental implants.
Dental professionals using the recalled scan adapter assemblies for dental implant procedures are most at risk. Patients receiving dental implants may experience delays in their treatment process.
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.
Identify if your scan adapter has part numbers 6035-09PT-M, 6043-09PT-M, or 6050-09PT-M with the listed lot numbers.
Part numbers 6035-09PT-M, 6043-09PT-M, and 6050-09PT-M with specific lot numbers are affected.
The recall is due to incorrect assembly of the scan adapter, which may cause delays in capturing dental implant positions during scanning.
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.
We’ve drafted a message you can send Implant Direct to request your refund or repair — edit it as you like.
Subject: Recall Z-0261-2020 — Implant Direct Implant Direct Hello, I own a Implant Direct that is covered by recall Z-0261-2020 from Implant Direct. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
