Thommen Medical recalls PF 4.0 impression copings with a manufacturing defect causing weak connection to implants. Affected units have specific model numbers and lot codes.
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Thommen Medical is recalling PF 4:0 impression copings that may not connect securely to dental implants. This could lead to improper fit and potential complications during dental procedures.
The impression coping may not stay firmly connected to the implant due to improper manufacturing of the internal canal. This could cause the coping to become loose during use, potentially leading to improper fit or damage to the implant.
Dentists and dental technicians who use these impression copings for dental implants are most likely affected. Patients receiving dental implants using this product could be at risk.
Check for the model number PF 4.0, article number 3.03.079, UDI/DI code 07640156475463, and lot number 30972 on the product packaging.
Look for the model number PF 4.0, article number 3.03.079, UDI/DI code 07640156475463, and lot number 30972 on the product packaging.
The recall indicates a manufacturing defect that could cause the impression coping to not connect securely to implants, but the risk is low as the product is not expected to cause serious injury in normal use.
Check for the model number PF 4.0, article number 3.03.079, UDI/DI code 07640156475463, and lot number 30972 on the product packaging.
The recall does not specify a remedy, so contact the manufacturer directly for guidance on next steps.
We’ve drafted a message you can send Thommen Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1322-2024 — Thommen Medical Thommen Medical Hello, I own a Thommen Medical that is covered by recall Z-1322-2024 from Thommen Medical. 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.
