Osteomed recalls OSTEOVATIONEX 2CC bone void filler kits with potential shelf-life issues. Products may not maintain setting characteristics for labeled duration.
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 2CC injectable bone void filler kits because they may not maintain their setting properties for the labeled shelf life. This could affect the healing process if the product fails to set properly.
The product may not maintain its setting characteristics for the labeled shelf life. This means the filler could fail to set properly during bone healing, potentially affecting the treatment outcome.
Patients using OSTEOVATIONEX 2CC for bone void fillers are affected. Those who have recently received the product and are in the healing process are most at risk.
Check for the product name OSTEOVATIONEX 2CC and lot numbers 1135741, 1130301, or 1127941. The product is used for bone void fillers in the healing process.
Look for lot numbers 1135741, 1130301, or 1127941 on the packaging.
The product may not maintain its setting characteristics for the labeled shelf life, which could affect bone healing.
The recall does not specify a remedy, so check the lot number and contact Osteomed for guidance.
The product is safe for use if it maintains its setting characteristics within the labeled shelf life, but there is a risk of failure.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2180-2020 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2180-2020 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.
