Osteomed recalls OSTEOVATIONEX 5CC Impact Formula due to potential shelf-life issues affecting bone void filler setting characteristics. Affected lots: 1128788, 1133246, 1126985, 1135313.
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 OSTEOVATIONEX 5CC Impact Formula bone void fillers because they may not maintain their setting properties for the labeled shelf life. This could lead to improper bone healing if used after the expiration date.
The product may not set properly within the labeled shelf life, which could affect bone healing. This happens because the filler's chemical properties degrade over time, leading to inconsistent performance.
Patients using bone void fillers for dental or orthopedic procedures who received the specific lots listed. Those with the product in their medical records are most at risk.
Check the lot numbers on the product: 1128788, 1133246, 1126985, or 1135313. The product is a bone void filler used in dental or orthopedic procedures.
Look for the lot numbers 1128788, 1133246, 1126985, or 1135313 on the product packaging.
The product may not maintain its setting characteristics for the labeled shelf-life duration, which could affect bone healing.
Check the lot number on the product. If it matches the affected lots listed, contact Osteomed for guidance.
The recall is for potential issues with the product's shelf life, not immediate safety risks. The hazard level is low risk.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2185-2020 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2185-2020 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.
