Osteomed recalls OSTEOVATION 3CC ImpactFormula due to incorrect shelf-life labeling. The product may not maintain setting characteristics for the labeled duration, potentially affecting bone healing. Affected units include specific lot numbers listed in the recall.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Osteomed is recalling OSTEOVATION 3CC ImpactFormula bone void filler kits because the shelf-life labeling is incorrect. This means the product might not set properly within the labeled time frame, which could impact bone healing after surgery.
The product's shelf-life is labeled incorrectly, so it may not maintain its setting characteristics for the full labeled duration. This could lead to the filler not properly hardening in the bone void, potentially affecting the healing process.
Patients who received OSTEOVATION 3CC ImpactFormula bone void filler kits during surgery are likely affected. Those with specific lot numbers listed in the recall are at risk of the product not setting correctly.
Check the product label for the lot numbers: 17051908, 17060107, 1132179, 1133245, 1135308, and 1142208. The product is a bone void filler used in surgical procedures.
Look for the lot numbers listed in the recall: 17051908, 17060107, 1132179, 1133245, 1135308, and 1142208.
The OSTEOVATION 3CC ImpactFormula is a bone void filler used during surgical procedures to fill bone voids that are replaced by bone during healing.
The product has incorrect shelf-life labeling, which means it may not maintain its setting characteristics for the labeled duration, potentially affecting bone healing.
The affected lot numbers are 17051908, 17060107, 1132179, 1133245, 1135308, and 1142208.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2187-2020 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2187-2020 from Osteomed. 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.
