DT MedTech recalls Hintermann Series H3 Poly Inlay Size 3 (Part 300305) due to incorrect package labeling. Affected units may not be properly identified.
Incorrect package labeling identifying the device
DT MedTech is recalling Hintermann Series H3 Poly Inlay Size 3 (5mm, Part 300305) because the packaging labels are incorrect. This could lead to confusion about the product's identity, which might affect proper use in mobile bearing ankle joint prostheses.
Incorrect package labeling means the product might not be properly identified. This could lead to confusion about which part is being used, potentially causing improper fitting or use in medical applications.
Patients using mobile bearing ankle joint prostheses with this specific part number are likely affected. Those who have the product but do not know the exact model or lot number may be at risk of misidentification.
Check for the part number 300305 on the packaging. The product is a Hintermann Series H3 Poly Inlay, Size 3 (5mm) used in mobile bearing ankle joint prostheses. Lot number AAADP is associated with this recall.
Verify the part number and lot number on the packaging to confirm if it matches the recalled item.
The recall is due to incorrect labeling, not safety issues. The product itself is safe but may be misidentified.
Look for part number 300305 and lot number AAADP on the packaging.
No, the recall does not require stopping use. The issue is labeling, not functionality.
We’ve drafted a message you can send DT MedTech to request your refund or repair — edit it as you like.
Subject: Recall Z-0402-2019 — DT MedTech DT MedTech Hello, I own a DT MedTech that is covered by recall Z-0402-2019 from DT MedTech. 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.
